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Tanezumab in Osteoarthritis Of The Hip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00744471
Recruitment Status : Completed
First Posted : September 1, 2008
Results First Posted : February 26, 2021
Last Update Posted : February 26, 2021
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
Conditions Arthritis
Osteoarthritis
Osteoarthritis, Hip
Interventions Biological: tanezumab
Biological: Placebo
Enrollment 627
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Period Title: Overall Study
Started 156 156 158 157
Treated 155 155 154 157
Completed 13 11 6 9
Not Completed 143 145 152 148
Reason Not Completed
Randomized but not treated             1             1             4             0
Death             0             0             0             1
Adverse Event             6             7             5             9
Withdrawal by Subject             9             9             15             12
Protocol Violation             1             4             1             2
Entered extension study             41             84             100             91
Other             2             3             6             2
Lack of Efficacy             83             37             19             31
Lost to Follow-up             0             0             2             0
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg Total
Hide Arm/Group Description Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. Total of all reporting groups
Overall Number of Baseline Participants 155 155 154 157 621
Hide Baseline Analysis Population Description
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous (IV) study medication (either tanezumab or matching placebo).
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 154 participants 157 participants 621 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 44 years
11
   7.1%
8
   5.2%
11
   7.1%
6
   3.8%
36
   5.8%
Between 45 and 64 years
84
  54.2%
86
  55.5%
74
  48.1%
82
  52.2%
326
  52.5%
>= 65 years
60
  38.7%
61
  39.4%
69
  44.8%
69
  43.9%
259
  41.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 154 participants 157 participants 621 participants
Female
103
  66.5%
101
  65.2%
92
  59.7%
88
  56.1%
384
  61.8%
Male
52
  33.5%
54
  34.8%
62
  40.3%
69
  43.9%
237
  38.2%
1.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline (Day 1), Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 7.26  (1.39) 7.20  (1.44) 7.24  (1.46) 7.33  (1.64)
Change at Week 16 -1.65  (2.44) -2.86  (2.73) -3.35  (2.76) -3.37  (2.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-1.87 to -0.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.69
Confidence Interval (2-Sided) 95%
-2.28 to -1.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-2.34 to -1.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site.BOCF method used to impute missing values. "Overall Number of participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.79  (1.56) 6.79  (1.63) 6.82  (1.70) 6.83  (1.83)
Change at Week 16 -1.39  (2.25) -2.54  (2.72) -2.88  (2.70) -2.96  (2.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-1.74 to -0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.49
Confidence Interval (2-Sided) 95%
-2.06 to -0.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-2.17 to -1.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Hide Description Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.47  (0.60) 3.55  (0.62) 3.51  (0.64) 3.46  (0.66)
Change at Week 16 -0.34  (0.69) -0.67  (0.87) -0.80  (1.00) -0.80  (0.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.51 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.64 to -0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.66 to -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline, Week 2, 4, 8, 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -1.94  (2.08) -3.32  (2.59) -3.71  (2.53) -3.30  (2.52)
Change at Week 4 -1.92  (2.17) -3.46  (2.64) -3.99  (2.63) -3.88  (2.74)
Change at Week 8 -1.74  (2.33) -2.76  (2.62) -3.36  (2.60) -3.70  (2.71)
Change at Week 12 -1.81  (2.44) -3.24  (2.89) -3.67  (2.79) -3.77  (2.98)
Change at Week 24 -1.45  (2.43) -2.54  (2.74) -3.00  (2.80) -3.06  (2.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-1.93 to -0.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.26 to -1.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.33
Confidence Interval (2-Sided) 95%
-1.85 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-2.11 to -1.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-2.57 to -1.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.95
Confidence Interval (2-Sided) 95%
-2.50 to -1.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-1.65 to -0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-2.20 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.00
Confidence Interval (2-Sided) 95%
-2.56 to -1.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.49
Confidence Interval (2-Sided) 95%
-2.10 to -0.88
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 Placebo, Tanezumab 5 mg
Comments Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.85
Confidence Interval (2-Sided) 95%
-2.46 to -1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-2.57 to -1.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.16
Confidence Interval (2-Sided) 95%
-1.75 to -0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.52
Confidence Interval (2-Sided) 95%
-2.12 to -0.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.20 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame Baseline, Week 2, 4, 8, 12, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -1.94  (2.08) -3.32  (2.59) -3.71  (2.53) -3.30  (2.52)
Change at Week 4 -2.02  (2.18) -3.55  (2.59) -4.04  (2.60) -4.04  (2.59)
Change at Week 8 -1.86  (2.32) -2.95  (2.50) -3.52  (2.61) -3.89  (2.69)
Change at Week 12 -2.12  (2.48) -3.58  (2.71) -4.03  (2.67) -4.35  (2.69)
Change at Week 16 -2.05  (2.47) -3.23  (2.59) -3.66  (2.74) -3.96  (2.61)
Change at Week 24 -1.97  (2.50) -3.16  (2.62) -3.56  (2.74) -3.77  (2.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-1.93 to -0.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.26 to -1.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.33
Confidence Interval (2-Sided) 95%
-1.85 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-2.08 to -1.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-2.52 to -1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-2.54 to -1.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.17
Confidence Interval (2-Sided) 95%
-1.71 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.66
Confidence Interval (2-Sided) 95%
-2.21 to -1.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.06
Confidence Interval (2-Sided) 95%
-2.60 to -1.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-2.11 to -0.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.88
Confidence Interval (2-Sided) 95%
-2.45 to -1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.26
Confidence Interval (2-Sided) 95%
-2.82 to -1.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.82 to -0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.59
Confidence Interval (2-Sided) 95%
-2.15 to -1.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.96
Confidence Interval (2-Sided) 95%
-2.51 to -1.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-1.85 to -0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-2.15 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.83
Confidence Interval (2-Sided) 95%
-2.40 to -1.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame Baseline, Week 2, 4, 8, 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -1.56  (2.01) -2.88  (2.53) -3.32  (2.50) -2.90  (2.46)
Change at Week 4 -1.44  (1.99) -3.06  (2.60) -3.62  (2.43) -3.40  (2.57)
Change at Week 8 -1.33  (2.21) -2.48  (2.66) -2.95  (2.45) -3.17  (2.61)
Change at Week 12 -1.52  (2.19) -2.86  (2.86) -3.27  (2.71) -3.39  (2.85)
Change at Week 24 -1.27  (2.18) -2.19  (2.65) -2.62  (2.61) -2.78  (2.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-1.83 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.23 to -1.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-1.83 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.12 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.12
Confidence Interval (2-Sided) 95%
-2.64 to -1.60
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 Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.94
Confidence Interval (2-Sided) 95%
-2.46 to -1.43
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 Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-1.72 to -0.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-2.18 to -1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-2.43 to -1.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.93 to -0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.31 to -1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-2.47 to -1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.52 to -0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.91 to -0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-2.09 to -0.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
Hide Description WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame Baseline, Week 2, 4, 8, 12, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -1.56  (2.01) -2.88  (2.53) -3.32  (2.50) -2.90  (2.46)
Change at Week 4 -1.51  (2.05) -3.13  (2.59) -3.67  (2.43) -3.52  (2.48)
Change at Week 8 -1.40  (2.24) -2.66  (2.64) -3.14  (2.44) -3.35  (2.64)
Change at Week 12 -1.61  (2.39) -3.12  (2.82) -3.58  (2.63) -3.85  (2.68)
Change at Week 16 -1.56  (2.41) -2.83  (2.72) -3.16  (2.72) -3.42  (2.60)
Change at Week 24 -1.46  (2.42) -2.71  (2.71) -3.09  (2.61) -3.34  (2.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-1.83 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.23 to -1.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-1.83 to -0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.59
Confidence Interval (2-Sided) 95%
-2.10 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-2.61 to -1.59
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 Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.00
Confidence Interval (2-Sided) 95%
-2.51 to -1.49
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 Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-1.83 to -0.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.72
Confidence Interval (2-Sided) 95%
-2.26 to -1.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-2.53 to -1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-2.11 to -1.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.93
Confidence Interval (2-Sided) 95%
-2.49 to -1.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.28
Confidence Interval (2-Sided) 95%
-2.83 to -1.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-1.87 to -0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-2.14 to -1.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.92
Confidence Interval (2-Sided) 95%
-2.47 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.30
Confidence Interval (2-Sided) 95%
-1.86 to -0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-2.17 to -1.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.91
Confidence Interval (2-Sided) 95%
-2.47 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Hide Description Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame Baseline, Week 2, 4, 8, 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -0.41  (0.83) -0.83  (0.94) -1.08  (1.02) -0.81  (0.92)
Change at Week 4 -0.44  (0.79) -0.93  (0.88) -1.16  (0.96) -0.97  (0.98)
Change at Week 8 -0.43  (0.86) -0.65  (0.93) -0.93  (1.03) -0.86  (0.94)
Change at Week 12 -0.41  (0.76) -0.78  (0.93) -1.03  (1.05) -0.92  (0.96)
Change at Week 24 -0.36  (0.72) -0.61  (0.84) -0.78  (1.00) -0.60  (0.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.55 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.83 to -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.60 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.65 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.88 to -0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.73 to -0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.39 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.68 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.65 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.55 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.81 to -0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-0.73 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.45 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.60 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.43 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
Hide Description Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame Baseline, Week 2, 4, 8, 12, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 150 150 155
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 2 -0.41  (0.83) -0.83  (0.94) -1.08  (1.02) -0.81  (0.92)
Change at Week 4 -0.45  (0.81) -0.95  (0.88) -1.17  (0.97) -1.03  (0.99)
Change at Week 8 -0.46  (0.90) -0.73  (0.95) -0.96  (1.04) -0.90  (0.96)
Change at Week 12 -0.44  (0.90) -0.87  (0.99) -1.14  (1.05) -1.01  (1.00)
Change at Week 16 -0.38  (0.86) -0.76  (0.95) -0.89  (1.05) -0.88  (0.99)
Change at Week 24 -0.42  (0.90) -0.71  (0.95) -0.90  (1.08) -0.74  (0.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.55 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.83 to -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.60 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.65 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-0.87 to -0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-0.76 to -0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.43 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.67 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.65 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.60 to -0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-0.88 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.79 to -0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.53 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.68 to -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-0.71 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 2.5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.47 to -0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 5 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.66 to -0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Tanezumab 10 mg
Comments Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is based on ANCOVA from pairwise comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.53 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
Hide Description A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Time Frame Week 2, 4, 8, 12, 16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
Hide Arm/Group Description:
Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.
Overall Number of Participants Analyzed 154 151 150 156
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 45.5 68.7 80.0 67.7
Week 4 45.5 71.3 79.3 74.8
Week 8 43.5 60.7 70.7 71.0
Week 12 39.6 63.3 70.0 66.5
Week 16 35.1 57.3 65.3 65.8
Week 24 30.5 50.7 62.0 58.7
11.Secondary Outcome
Title Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
Hide Description A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Time Frame Week 2, 4, 8, 12 ,16, 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values.
Arm/Group Title Placebo Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg