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Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain (TANGO)

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ClinicalTrials.gov Identifier: NCT02725411
Recruitment Status : Completed
First Posted : April 1, 2016
Results First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: Celecoxib
Biological: Tanezumab 5 mg
Biological: Tanezumab 10 mg
Drug: Placebo for celecoxib
Biological: Placebo for tanezumab
Enrollment 277
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80). Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80). Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Period Title: Treatment Period (56 Weeks)
Started 92 93 92
Treated 92 93 92
Completed 62 43 43
Not Completed 30 50 49
Reason Not Completed
Adverse Event             3             5             4
Lack of Efficacy             1             4             1
Lost to Follow-up             0             1             0
Other             1             4             5
Withdrawal by Subject             0             1             4
Not Met Protocol-Specified Criteria             25             35             35
Period Title: Follow-up Period (24 Weeks)
Started 92 [1] 93 [1] 92 [1]
Completed 88 82 87
Not Completed 4 11 5
Reason Not Completed
Adverse Event             1             1             0
Lack of Efficacy             0             2             0
Lost to Follow-up             1             1             0
Other             1             4             2
Withdrawal by Subject             1             3             3
[1]
All participants on either completion or discontinuation of treatment, entered follow up period.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib Total
Hide Arm/Group Description Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80). Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80). Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80). Total of all reporting groups
Overall Number of Baseline Participants 92 93 92 277
Hide Baseline Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 93 participants 92 participants 277 participants
53.35  (12.97) 52.32  (14.02) 54.34  (14.21) 53.33  (13.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 93 participants 92 participants 277 participants
Female
37
  40.2%
44
  47.3%
38
  41.3%
119
  43.0%
Male
55
  59.8%
49
  52.7%
54
  58.7%
158
  57.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 93 participants 92 participants 277 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
92
 100.0%
93
 100.0%
92
 100.0%
277
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 93 participants 92 participants 277 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
92
 100.0%
93
 100.0%
92
 100.0%
277
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Time Frame Baseline (Day 1) up to 24 weeks after last dose of study drug (up to Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
70
  76.1%
63
  67.7%
67
  72.8%
Participants with SAEs
8
   8.7%
11
  11.8%
4
   4.3%
2.Primary Outcome
Title Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks after last dose of study drug (up to Week 80). Relatedness to study drug was assessed by the investigator. AEs included both serious and non-serious AEs.
Time Frame Baseline up to 24 weeks after last dose of study drug (up to Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with treatment related AEs
11
  12.0%
7
   7.5%
12
  13.0%
Participants with treatment related SAEs
1
   1.1%
1
   1.1%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Test Abnormalities
Hide Description Abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; white blood cell count<0.6*LLN, >1.5*ULN; lymphocytes, leukocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase >2.0*ULN; nitrite >=1. Investigator judged clinical significance of laboratory test abnormalities.
Time Frame Baseline up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.1%
0
   0.0%
1
   1.1%
4.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs Abnormalities
Hide Description Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate. Investigator judged clinical significance of vital signs' abnormalities.
Time Frame Baseline up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.3%
2
   2.2%
5
   5.4%
5.Primary Outcome
Title Number of Participants With Confirmed Orthostatic Hypotension From Baseline up to Week 80
Hide Description Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP >=20 mmHg or reduction in diastolic BP >=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (>) 150 mmHg (mean supine): reduction in systolic BP >=30 mmHg or reduction in diastolic BP >=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Time Frame Baseline up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   2.2%
0
   0.0%
6.Primary Outcome
Title Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 24
Hide Description SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.
Time Frame Screening (up to 37 days before Day 1), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Screening Number Analyzed 92 participants 93 participants 92 participants
0.76  (1.51) 0.86  (1.58) 1.10  (1.78)
Change at Week 24 Number Analyzed 63 participants 46 participants 46 participants
0.79  (2.29) 0.93  (3.36) 0.04  (2.66)
7.Primary Outcome
Title Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 56
Hide Description SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.
Time Frame Screening, Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 62 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.89  (3.30) 0.86  (4.10) 0.35  (2.60)
8.Primary Outcome
Title Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Week 80
Hide Description SAS is a participant rated 12 items questionnaire for males and 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during the past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants were asked to answer "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If a participant answered "Yes" for a symptom, then impact of that symptom was rated on a 5 point scale, ranged from 1 (least sever impact) to 5 (most severe impact), where higher scores signified more severe impact of symptoms. The total symptom impact score was calculated as the sum of impact of all symptoms. Overall possible range for the total symptom impact score was 0 (no impact) to 60 (extreme impact) for males and 0 (no impact) to 55 (extreme impact) for females, higher scores indicated more severe impact of symptoms on participants' well-being.
Time Frame Screening, Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 62 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.69  (2.81) 1.26  (3.29) 0.72  (3.17)
9.Primary Outcome
Title Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 1
Hide Description SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If participant answered "Yes" for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 1 at 8 weeks after last dose of tanezumab or placebo matched to tanezumab.
Time Frame Screening, Early Termination Follow-up Visit 1 (at 8 weeks after last dose of tanezumab or placebo matched to tanezumab)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 30 49 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.50  (5.28) 0.82  (3.42) 2.15  (3.94)
10.Primary Outcome
Title Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 3
Hide Description SAS: participant rated 12 items questionnaire for males; 11 items questionnaire for females. SAS measures autonomic symptoms of neuropathy and their impact on participants' well-being, during past 6 months. Each item was related to a symptom/health problem. At scheduled time points, participants answered "Yes" or "No" for each of symptoms/health problems experienced during past 6 months. If participant answered "Yes" for a symptom, then impact of that symptom was rated on 5 point scale (1 [least sever impact] to 5 [most severe impact]); higher scores = more severe impact of symptoms. Total impact score = sum of impact of all symptoms; range for males =0 (no impact) to 60 (extreme impact); females =0 (no impact) to 55 (extreme impact); higher scores = more severe impact of symptoms on participants' well-being. Participants discontinuing from study treatment before Week 56, had early termination follow-up visit 3 at 24 weeks after last dose of tanezumab or placebo matched to tanezumab.
Time Frame Screening, Early Termination Follow-up Visit 3 (at 24 weeks after last dose of tanezumab or placebo matched to tanezumab)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab. Here, "Overall number of participants analyzed" signifies only those participants who were evaluable for this outcome measure.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 27 45 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.89  (5.57) 1.60  (3.82) 0.88  (3.03)
11.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Assessments
Hide Description Electrocardiogram assessment included PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), RR intervals, and heart rate. Investigator judged clinical significance of electrocardiogram assessment.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.2%
0
   0.0%
2
   2.2%
12.Primary Outcome
Title Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event
Hide Description Percentage of participants with individual joint safety adjudication outcomes: rapidly progressive osteoarthritis (OA) type-1 only, rapidly progressive OA type-2 only, primary osteonecrosis, pathological fracture and subchondral insufficiency fracture is reported. Rapidly progressive (RP) OA type 1 events were those that the adjudication committee considered to have significant loss of joint space width >= 2 millimeter within approximately 1 year without gross structural failure. RP OA type 2 events were those considered to have destruction of bone including limited or total collapse of at least 1 subchondral surface that is not normally present in conventional end-stage osteoarthritis. Subchondral insufficiency fractures are a type of stress fractures which occur below the cartilage on the weight bearing surface of a bone.
Time Frame Baseline up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Rapidly Progressive OA type 1
1
(0.0 to 5.9)
0
(0.0 to 3.9)
0
(0.0 to 3.9)
Rapidly Progressive OA type 2
0
(0.0 to 3.9)
1
(0.0 to 5.8)
0
(0.0 to 3.9)
Primary Osteonecrosis
0
(0.0 to 3.9)
0
(0.0 to 3.9)
0
(0.0 to 3.9)
Pathological Fracture
0
(0.0 to 3.9)
0
(0.0 to 3.9)
0
(0.0 to 3.9)
Subchondral Insufficiency Fracture
0
(0.0 to 3.9)
1
(0.0 to 5.8)
0
(0.0 to 3.9)
13.Primary Outcome
Title Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event
Hide Description Individual adjudicated joint safety outcomes/event: rapidly progressive OA (type-1,type-2), primary osteonecrosis, pathological fracture and subchondral insufficiency fracture. Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Event rate for any individual adjudicated joint safety outcome/event = the number of events per 1000 participant-years at risk.
Time Frame Baseline (Day 1) up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
Rapidly Progressive OA Type 1
8.9
(1.2 to 62.9)
0
(0 to 0)
0
(0 to 0)
Rapidly Progressive OA Type 2
0
(0 to 0)
10.4
(1.5 to 74.1)
0
(0 to 0)
Primary Osteonecrosis
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Pathological Fracture
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Subchondral Insufficiency Fracture
0
(0 to 0)
10.5
(1.5 to 74.6)
0
(0 to 0)
14.Primary Outcome
Title Percentage of Participants With At Least 1 Total Joint Replacement
Hide Description Percentage of participants with at least 1 total knee, total hip or total shoulder joint replacement were reported.
Time Frame Baseline (Day 1) up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 3.9)
1
(0.0 to 5.8)
0
(0.0 to 3.9)
15.Primary Outcome
Title Observation Time-Adjusted Event Rate for Total Joint Replacement (TJR) Event
Hide Description Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant had no TJR, or (ii) date of TJR (earliest TJR within each participant in the case of multiple TJRs). Event rate = number of events per 1000 participant-years at risk.
Time Frame Baseline (Day 1) up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
0
(0 to 0)
10.4
(1.5 to 74.1)
0
(0 to 0)
16.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.84  (2.39) 1.01  (4.06) 0.87  (2.19)
Change at Week 2 -0.04  (0.25) -0.01  (0.48) 0.11  (1.19)
17.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.08  (0.50) -0.02  (0.68) 0.11  (1.08)
18.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.04  (0.39) 0.15  (0.78) 0.13  (0.99)
19.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.02  (0.21) 0.05  (0.71) 0.01  (0.87)
20.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.02  (0.21) 0.09  (0.70) 0.28  (1.83)
21.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.00  (0.36) -0.01  (0.96) 0.04  (1.64)
22.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.14  (1.14) 0.04  (1.03) 0.04  (1.64)
23.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (1.09) -0.01  (0.97) 0.04  (1.70)
24.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 56
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (1.09) -0.02  (0.97) 0.04  (1.64)
25.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 64
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.18  (1.43) 0.01  (0.98) 0.04  (1.70)
26.Primary Outcome
Title Change From Baseline in Neuropathy Impairment Score (NIS) at Week 80
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time Frame Baseline, Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.03  (1.26) 0.00  (0.97) 0.17  (2.36)
27.Primary Outcome
Title Largest Change From Baseline in Neuropathy Impairment Score (NIS) to Any Post-baseline Visit
Hide Description NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. Largest change from baseline here means worst post- baseline change value (among all change from baseline values).
Time Frame Baseline to any post-baseline visit (until Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.33  (1.47) 0.37  (1.06) 0.78  (2.62)
28.Primary Outcome
Title Number of Participants With Anti Tanezumab Antibodies From Baseline up to Week 80
Hide Description Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a validated analytical method. Number of participants with presence of anti-tanezumab antibodies are reported.
Time Frame Baseline up to Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
21
  22.8%
41
  44.1%
62
  67.4%
29.Primary Outcome
Title Number of Participants With Abnormal Physical Examination Findings
Hide Description Physical examination included assessment of general appearance, skin, head, neck, eyes, ears, nose, throat, abdomen, lungs, heart, thyroid, and extremities. Investigator judged abnormality in physical examinations. Only those rows have been reported which had at least 1 participant with abnormality data in any of the reporting arms.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were treated with tanezumab or placebo matched to tanezumab.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
Skin
1
   1.1%
0
   0.0%
3
   3.3%
Neck
2
   2.2%
1
   1.1%
0
   0.0%
Eyes
1
   1.1%
1
   1.1%
1
   1.1%
Ear
0
   0.0%
1
   1.1%
2
   2.2%
Nose
0
   0.0%
0
   0.0%
1
   1.1%
Extremities
0
   0.0%
1
   1.1%
1
   1.1%
Heart
2
   2.2%
3
   3.2%
1
   1.1%
30.Secondary Outcome
Title Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation
Hide Description Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all randomized participants who received at least 1 dose of SC study medication (either tanezumab or placebo matched to tanezumab). Missing data were imputed with multiple imputation method based on the reason for missing data.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 2 -0.47  (0.14) -0.69  (0.14) -0.46  (0.14)
Change at Week 4 -0.83  (0.17) -1.05  (0.17) -0.56  (0.17)
Change at Week 8 -1.24  (0.20) -1.64  (0.20) -1.07  (0.20)
Change at Week 12 -2.19  (0.23) -2.46  (0.23) -1.85  (0.23)
Change at Week 16 -2.91  (0.23) -2.51  (0.23) -2.28  (0.23)
Change at Week 24 -2.88  (0.28) -2.41  (0.28) -2.11  (0.29)
Change at Week 32 -2.95  (0.29) -2.34  (0.30) -2.08  (0.30)
Change at Week 40 -3.00  (0.30) -2.32  (0.30) -2.06  (0.29)
Change at Week 48 -3.07  (0.30) -2.31  (0.31) -2.09  (0.31)
Change at Week 56 -2.98  (0.29) -2.22  (0.30) -2.13  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.38 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.60 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.70 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.93 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.69 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.09 to -0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.94 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.21 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.24 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.84 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.53 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-1.07 to 0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.65 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-1.06 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.72 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-1.05 to 0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.80 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-1.04 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.65 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.88 to 0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in Average Low Back Pain Intensity (LBPI) at Week 64: Observed Data
Hide Description Average LBPI was assessed on an 11-point NRS. Participants described their average LBPI during the past 24 hours (at each specified/scheduled time-point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analyzed. ''Overall number of participants analyzed'' = participants who were evaluable for this outcome measure. Observed data: analysis was performed using all available data at Week 64, and no imputation technique was used for missing data.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 61 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.60  (1.81) -3.96  (1.82) -3.46  (1.89)
32.Secondary Outcome
Title Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation
Hide Description The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Missing data were imputed with multiple imputation method based on the reason for missing data.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 2 -2.09  (0.34) -2.09  (0.34) -1.23  (0.34)
Change at Week 4 -2.41  (0.40) -2.35  (0.40) -1.89  (0.39)
Change at Week 8 -2.74  (0.39) -3.23  (0.39) -2.68  (0.39)
Change at Week 16 -3.85  (0.41) -4.38  (0.42) -3.84  (0.42)
Change at Week 24 -3.58  (0.48) -3.32  (0.47) -3.16  (0.48)
Change at Week 32 -3.62  (0.48) -3.11  (0.49) -3.02  (0.49)
Change at Week 40 -3.98  (0.50) -2.95  (0.50) -2.90  (0.51)
Change at Week 48 -3.99  (0.48) -2.96  (0.51) -3.19  (0.50)
Change at Week 56 -3.95  (0.49) -2.91  (0.50) -2.94  (0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.77 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-1.96 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.48 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-1.43 to 0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-1.04 to 0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.53 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-1.06 to 1.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.60 to 0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-1.71 to 0.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-1.47 to 1.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.90 to 0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-1.44 to 1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-2.43 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-1.41 to 1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-2.17 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-1.16 to 1.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-2.37 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-1.35 to 1.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.71
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 64: Observed Data
Hide Description The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. Participants were asked to check/select only those items out of 24 items, which described them at each specified time point. The total number of items checked in questionnaire was equal to RMDQ total score, overall possible score ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater/more disability.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analyzed. "Overall number of participants analyzed" = participants who were evaluable for this outcome measure. Observed data: analysis was performed using all available data at Week 64 and no imputation technique was used for missing data.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 62 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.55  (4.04) -5.72  (4.61) -5.02  (3.96)
34.Secondary Outcome
Title Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Hide Description PGA of low back pain was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1 to 5, using interactive response technology (IRT), where 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 92 participants 93 participants 92 participants
3.24  (0.45) 3.14  (0.38) 3.13  (0.34)
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-0.43  (0.63) -0.40  (0.63) -0.28  (0.52)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-0.48  (0.72) -0.46  (0.73) -0.37  (0.59)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-0.62  (0.74) -0.66  (0.77) -0.44  (0.66)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-0.92  (0.75) -0.82  (0.72) -0.81  (0.74)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-1.10  (0.69) -1.22  (0.62) -0.96  (0.62)
Change at Week 32 Number Analyzed 63 participants 46 participants 46 participants
-1.14  (0.69) -1.13  (0.65) -0.91  (0.55)
Change at Week 40 Number Analyzed 63 participants 45 participants 44 participants
-1.29  (0.73) -1.09  (0.60) -1.02  (0.59)
Change at Week 48 Number Analyzed 63 participants 45 participants 44 participants
-1.21  (0.70) -1.11  (0.57) -1.02  (0.66)
Change at Week 56 Number Analyzed 63 participants 43 participants 43 participants
-1.13  (0.68) -1.14  (0.56) -1.07  (0.59)
Change at Week 64 Number Analyzed 62 participants 43 participants 43 participants
-0.94  (0.72) -0.84  (0.61) -0.86  (0.71)
35.Secondary Outcome
Title Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56
Hide Description Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with cumulative reduction (as percent change) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100%) in average LBPI from baseline to weeks 16, 24 and 56 were reported. Participants (%) might have been counted more than once under various rows.
Time Frame Baseline, Weeks 16, 24 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab).
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Unit of Measure: percentage of participants
Week 16: >0% 89.1 81.7 81.5
Week 16: >=10% 85.9 77.4 78.3
Week 16: >=20% 76.1 67.7 66.3
Week 16: >=30% 71.7 57.0 58.7
Week 16: >=40% 59.8 46.2 45.7
Week 16: >=50% 51.1 35.5 32.6
Week 16: >=60% 33.7 25.8 16.3
Week 16: >=70% 19.6 17.2 8.7
Week 16: >=80% 13.0 14.0 6.5
Week 16: >=90% 3.3 4.3 2.2
Week 16: =100% 3.3 4.3 2.2
Week 24: >0% 72.8 60.2 59.8
Week 24: >=10% 70.7 57.0 57.6
Week 24: >=20% 69.6 55.9 55.4
Week 24: >=30% 65.2 51.6 53.3
Week 24: >=40% 57.6 48.4 46.7
Week 24: >=50% 50.0 43.0 38.0
Week 24: >=60% 38.0 35.5 20.7
Week 24: >=70% 25.0 21.5 10.9
Week 24: >=80% 17.4 16.1 4.3
Week 24: >=90% 6.5 4.3 1.1
Week 24: =100% 2.2 3.2 0
Week 56: >=0% 68.5 51.6 52.2
Week 56: >=10% 68.5 50.5 51.1
Week 56: >=20% 64.1 50.5 51.1
Week 56: >=30% 63.0 47.3 51.1
Week 56: >=40% 59.8 43.0 44.6
Week 56: >=50% 53.3 38.7 41.3
Week 56: >=60% 41.3 33.3 32.6
Week 56: >=70% 35.9 25.8 17.4
Week 56: >=80% 23.9 14.0 10.9
Week 56: >=90% 9.8 4.3 1.1
Week 56: =100% 4.3 2.2 1.1
36.Secondary Outcome
Title Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56
Hide Description Average LBPI was assessed on an 11-point numeric rating scale (NRS). Participants described their average LBPI during the past 24 hours (at each specified/scheduled time point) on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. Percentage of participants with reduction in average LBPI of at least (>=) 30%, 50%, 70% and 90% at Weeks 16, 24, 40, and 56 compared to baseline are reported here. Participants (%) might have been counted more than once under various rows.
Time Frame Baseline, Weeks 16, 24, 40 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab).
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 16: At least 30% reduction
71.7
(61.8 to 80.0)
57.0
(46.8 to 66.6)
58.7
(48.5 to 68.2)
Week 16: At least 50% reduction
51.1
(41.0 to 61.1)
35.5
(26.5 to 45.6)
32.6
(23.9 to 42.7)
Week 16: At least 70% reduction
19.6
(12.7 to 28.9)
17.2
(10.8 to 26.2)
8.7
(4.3 to 16.4)
Week 16: At least 90% reduction
3.3
(0.7 to 9.6)
4.3
(1.3 to 10.9)
2.2
(0.1 to 8.1)
Week 24: At least 30% reduction
65.2
(55.0 to 74.2)
51.6
(41.6 to 61.5)
53.3
(43.1 to 63.1)
Week 24: At least 50% reduction
50.0
(40.0 to 60.0)
43.0
(33.4 to 53.2)
38.0
(28.8 to 48.3)
Week 24: At least 70% reduction
25.0
(17.2 to 34.8)
21.5
(14.3 to 31.0)
10.9
(5.8 to 19.0)
Week 24: At least 90% reduction
6.5
(2.8 to 13.8)
4.3
(1.3 to 10.9)
1.1
(0.0 to 6.5)
Week 40: At least 30% reduction
66.3
(56.1 to 75.2)
48.4
(38.5 to 58.4)
48.9
(38.9 to 59.0)
Week 40: At least 50% reduction
53.3
(43.1 to 63.1)
40.9
(31.4 to 51.0)
35.9
(26.8 to 46.1)
Week 40: At least 70% reduction
34.8
(25.8 to 45.0)
24.7
(17.0 to 34.4)
17.4
(10.9 to 26.5)
Week 40: At least 90% reduction
7.6
(3.5 to 15.1)
5.4
(2.0 to 12.3)
0
(0.0 to 4.8)
Week 56: At least 30% reduction
63.0
(52.8 to 72.2)
47.3
(37.5 to 57.4)
51.1
(41.0 to 61.1)
Week 56: At least 50% reduction
53.3
(43.1 to 63.1)
38.7
(29.4 to 48.9)
41.3
(31.8 to 51.5)
Week 56: At least 70% reduction
35.9
(26.8 to 46.1)
25.8
(17.9 to 35.6)
17.4
(10.9 to 26.5)
Week 56: At least 90% reduction
9.8
(5.0 to 17.8)
4.3
(1.3 to 10.9)
1.1
(0.0 to 6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
-0.8 to 26.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-15.8 to 12.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
4.2 to 32.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-10.7 to 16.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 10.9
Confidence Interval (2-Sided) 95%
0.6 to 20.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
-1.4 to 18.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 16: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-4.3 to 6.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 16: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-3.7 to 7.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
-2.3 to 25.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-15.9 to 12.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
-2.4 to 25.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-9.1 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 14.1
Confidence Interval (2-Sided) 95%
2.9 to 24.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
-0.2 to 21.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 24: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-0.7 to 11.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 24: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-2.2 to 8.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
3.1 to 30.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-14.8 to 13.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
3.0 to 31.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-9.0 to 18.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
4.6 to 29.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-4.5 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 40: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
1.4 to 13.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 40: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-0.1 to 10.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
-2.4 to 25.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: >=30%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-17.9 to 10.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
-2.5 to 25.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: >=50%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-16.5 to 11.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
5.6 to 30.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: >=70%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
-3.6 to 20.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Tanezumab 5 mg, Celecoxib
Comments Week 56: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
1.6 to 15.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Tanezumab 10 mg, Celecoxib
Comments Week 56: >=90%
Type of Statistical Test Other
Comments No formal hypotheses were tested in the study.
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-2.2 to 8.5
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
Hide Description BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified time points. BPI-sf scores for worst pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain at its worst in the last 24 hours; higher scores indicated worse pain.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-0.82  (1.26) -0.81  (1.67) -0.61  (1.48)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-1.25  (1.82) -1.22  (1.89) -0.95  (1.68)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-1.65  (1.97) -1.89  (2.18) -1.28  (1.69)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-3.26  (2.03) -2.92  (2.32) -2.67  (2.13)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-4.27  (1.99) -4.78  (1.81) -4.13  (1.79)
Change at Week 40 Number Analyzed 63 participants 44 participants 44 participants
-4.70  (1.85) -4.64  (1.59) -4.39  (1.85)
Change at Week 56 Number Analyzed 63 participants 43 participants 43 participants
-4.76  (1.96) -4.70  (2.03) -4.47  (1.91)
Change at Week 64 Number Analyzed 62 participants 43 participants 43 participants
-3.71  (2.25) -3.51  (1.99) -3.91  (2.28)
38.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
Hide Description BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for average pain: participants were asked to rate their pain by circling any 1 number from 0 (no pain) to 10 (pain as bad as you can imagine) that best describes their pain on average in the last 24 hours; higher scores indicated worse pain.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-0.68  (1.35) -0.78  (1.44) -0.50  (1.36)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-1.12  (1.75) -1.28  (1.72) -1.01  (1.43)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-1.49  (1.84) -1.87  (1.99) -1.16  (1.73)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-3.07  (2.03) -3.07  (2.03) -2.57  (1.89)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-4.10  (1.73) -4.66  (1.52) -3.92  (1.66)
Change at Week 40 Number Analyzed 63 participants 44 participants 44 participants
-4.38  (1.46) -4.50  (1.39) -4.16  (1.61)
Change at Week 56 Number Analyzed 63 participants 43 participants 43 participants
-4.43  (1.70) -4.42  (1.59) -4.30  (1.63)
Change at Week 64 Number Analyzed 62 participants 43 participants 43 participants
-3.53  (1.93) -3.72  (1.62) -3.70  (1.91)
39.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
Hide Description BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. Pain interference index was calculated as the mean of the 7 BPI-sf pain interference items: pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Each of the 7 items had score range from 0 (does not interfere) to 10 (completely interferes), higher scores indicated more interference in daily activities due to pain. Overall score range for pain interference index was 0 (no interference) to 10 (complete interference), higher score = higher interference.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-0.98  (1.76) -0.87  (1.51) -0.78  (1.94)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-1.43  (1.94) -1.32  (1.74) -1.16  (1.92)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-1.75  (1.99) -1.84  (1.93) -1.51  (2.14)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-2.98  (2.10) -2.70  (2.13) -2.62  (2.39)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-3.76  (2.07) -3.74  (2.02) -3.52  (1.97)
Change at Week 40 Number Analyzed 63 participants 44 participants 44 participants
-3.88  (1.92) -3.48  (2.02) -3.69  (2.03)
Change at Week 56 Number Analyzed 63 participants 43 participants 43 participants
-3.86  (2.09) -3.79  (1.95) -3.54  (2.25)
Change at Week 64 Number Analyzed 62 participants 43 participants 43 participants
-3.31  (2.26) -3.29  (2.07) -3.17  (2.42)
40.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
Hide Description BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with general activity: participants were asked to circle from any 1 number from 0 (no interference) to 10 (complete interference) that described how, during the past 24 hours, pain has interfered with their general activity; higher scores indicated higher interference.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
Hide Arm/Group Description:
Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-1.10  (1.95) -1.05  (1.95) -0.67  (2.20)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-1.68  (2.52) -1.54  (2.26) -1.26  (2.20)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-2.04  (2.44) -2.04  (2.61) -1.77  (2.40)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-3.29  (2.49) -3.04  (2.56) -2.92  (2.45)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-4.30  (2.26) -4.62  (2.00) -4.06  (2.04)
Change at Week 40 Number Analyzed 63 participants 44 participants 44 participants
-4.59  (2.07) -4.36  (2.11) -4.23  (1.99)
Change at Week 56 Number Analyzed 63 participants 43 participants 43 participants
-4.49  (2.21) -4.65  (1.97) -4.19  (2.21)
Change at Week 64 Number Analyzed 62 participants 43 participants 43 participants
-3.89  (2.46) -3.88  (2.33) -3.63  (2.23)
41.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
Hide Description BPI-sf is a self-administered questionnaire to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation at specified/scheduled time points. BPI-sf scores for pain interference with walking ability: participants were asked to circle from any 1 number from 0 (does not interfere) to 10 (completely interferes) that described how, during the past 24 hours, pain has interfered with their walking ability; higher scores indicated higher interference.
Time Frame Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
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Hide Analysis Population Description
ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or placebo matched to tanezumab). Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Tanezumab 5 mg Tanezumab 10 mg Celecoxib
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Participants were randomized to receive tanezumab (PF-04383119) 5 milligram (mg) subcutaneous (SC) injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive tanezumab (PF-04383119) 10 mg SC injection once every 8 weeks, from Day 1 up to Week 56 and oral placebo capsules matched to celecoxib, twice daily, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Participants were randomized to receive celecoxib 100 mg capsules orally, twice daily, from Day 1 up to Week 56 and SC injection of placebo matched to tanezumab (PF-04383119) once every 8 weeks, from Day 1 up to Week 56. Participants were followed up for 24 weeks after last dose of study drug (maximum up to Week 80).
Overall Number of Participants Analyzed 92 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 2 Number Analyzed 92 participants 93 participants 92 participants
-0.89  (2.33) -1.06  (2.13) -0.73  (2.26)
Change at Week 4 Number Analyzed 92 participants 92 participants 91 participants
-1.37  (2.49) -1.23  (2.35) -1.12  (2.40)
Change at Week 8 Number Analyzed 92 participants 92 participants 90 participants
-1.59  (2.41) -1.91  (2.41) -1.37  (2.54)
Change at Week 16 Number Analyzed 91 participants 89 participants 88 participants
-2.89  (2.53) -2.60  (2.63) -2.52  (2.86)
Change at Week 24 Number Analyzed 63 participants 50 participants 48 participants
-3.81  (2.51) -3.76  (2.40) -3.44  (2.01)
Change at Week 40 Number Analyzed 63 participants 44 participants 44 participants
-3.78  (2.30) -3.36  (2.26) -3.64  (2.04)
Change at Week 56 Number Analyzed 63 parti