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Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab (ANTIBODY-RA)

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: NCT01981473
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Rheumatoid Arthritis
Intervention Other: no intervention
Enrollment 605
Recruitment Details This is a multicenter, non-interventional (NI) study conducted to evaluate data collected from a cross sectional population of participants with rheumatoid arthritis (RA) who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Pre-assignment Details Participants treated with one of the three targeted therapies were enrolled using interactive response technology to assure data for approximately 200 participants were included for each RA treatment.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Period Title: Overall Study
Started 202 199 204
Completed 200 199 196
Not Completed 2 0 8
Reason Not Completed
Incorrect diagnosis of RA             0             0             1
Received treatment for < 6 months             0             0             1
Received treatment for >24 months             2             0             6
Arm/Group Title Etanercept Adalimumab Infliximab Total
Hide Arm/Group Description Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Total of all reporting groups
Overall Number of Baseline Participants 200 199 196 595
Hide Baseline Analysis Population Description
The full analysis set (FAS) composed of participants who had diagnosis of RA and who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and a maximum of 24 months prior to the study visit. Data was not collected or analyzed on participants who entered the study but did not complete based on not meeting criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 199 participants 196 participants 595 participants
56.5  (13.37) 54.3  (12.95) 60.7  (13.01) 57.1  (13.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 199 participants 196 participants 595 participants
Female
155
  77.5%
162
  81.4%
157
  80.1%
474
  79.7%
Male
45
  22.5%
37
  18.6%
39
  19.9%
121
  20.3%
1.Primary Outcome
Title Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Hide Description Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab/ Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 394
Measure Type: Number
Unit of Measure: Percentage of participants
0 24.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Adalimumab/ Infliximab
Comments This sample was to provide >95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments As there was only one primary endpoint, no adjustment was made for multiple comparisons.
Method Fisher Exact
Comments Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher’s exact test was used.
2.Secondary Outcome
Title Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).
Hide Description Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title % AA+ % AA-
Hide Arm/Group Description:
Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
Overall Number of Participants Analyzed 94 484
Measure Type: Number
Unit of Measure: percentage of participants
56.4 62.0
3.Secondary Outcome
Title Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 195
Mean (Standard Deviation)
Unit of Measure: µg/mL
AA+ NA [1]   (NA) 1.5  (2.24) 0.2  (0.90)
AA- 1.8  (1.03) 7.7  (4.72) 9.8  (15.25)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
4.Secondary Outcome
Title Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
Hide Description Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 195
Measure Type: Number
Unit of Measure: Percentage of participants
0 31.2 17.4
5.Secondary Outcome
Title The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 194
Mean (Standard Deviation)
Unit of Measure: units on a scale
AA+ NA [1]   (NA) 17.3  (13.56) 21.7  (16.12)
AA- 12.6  (10.62) 16.3  (14.83) 18.5  (13.84)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
6.Secondary Outcome
Title The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
AA+ NA [1]   (NA) 18.5  (14.52) 23.1  (16.33)
AA- 13.5  (10.95) 16.8  (14.91) 19.2  (13.89)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
7.Secondary Outcome
Title Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 197 197 185
Mean (Standard Deviation)
Unit of Measure: Units on a scale
AA+ NA [1]   (NA) 3.1  (1.22) 3.5  (1.33)
AA- 2.5  (1.20) 2.8  (1.43) 3.1  (1.31)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
8.Secondary Outcome
Title Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 195
Mean (Standard Deviation)
Unit of Measure: Units on a scale
AA+ NA [1]   (NA) 3.4  (1.22) 3.7  (1.30)
AA- 2.9  (1.18) 3.1  (1.36) 3.4  (1.26)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
9.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as “unable to do.” Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 195
Mean (Standard Deviation)
Unit of Measure: Units on a scale
AA+ NA [1]   (NA) 1.0  (0.75) 1.2  (0.69)
AA- 0.8  (0.68) 0.9  (0.70) 1.0  (0.63)
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
10.Secondary Outcome
Title Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Hide Description HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 200 199 195
Measure Type: Number
Unit of Measure: percentage of participants
% AA+ NA [1]  30.6 20.6
% AA- 42.5 36.5 26.1
[1]
There were no participants in ETN arm tested positive for anti-etanercept antibody.
11.Secondary Outcome
Title Correlation of Antidrug Antibody Titers With Efficacy Measures.
Hide Description Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 0 199 195
Measure Type: Number
Unit of Measure: Correlation coefficient
CDAI 0.07447 0.05256
SDAI 0.08970 0.06806
DAS28-ESR 0.12179 0.08950
DAS28-CRP 0.12710 0.08366
12.Secondary Outcome
Title Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
Hide Description Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description:
Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Overall Number of Participants Analyzed 0 199 195
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.69017 -0.60542
Time Frame From the signing of the informed consent until the follow-up visit (+28 days) following the assessment visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept Adalimumab Infliximab
Hide Arm/Group Description Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
All-Cause Mortality
Etanercept Adalimumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept Adalimumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/200 (0.50%)   0/199 (0.00%)   1/196 (0.51%) 
Investigations       
Blood Count Abnormal * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Renal and urinary disorders       
Renal Failure * 1  1/200 (0.50%)  0/199 (0.00%)  0/196 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept Adalimumab Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/200 (2.50%)   4/199 (2.01%)   11/196 (5.61%) 
Blood and lymphatic system disorders       
Neutropenia * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Cardiac disorders       
Atrial Fibrillation * 1  1/200 (0.50%)  0/199 (0.00%)  0/196 (0.00%) 
General disorders       
Fatigue * 1  0/200 (0.00%)  1/199 (0.50%)  0/196 (0.00%) 
Injection Site Reaction * 1  0/200 (0.00%)  2/199 (1.01%)  0/196 (0.00%) 
Infections and infestations       
Clostridium Difficile Colitis * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Nasopharyngitis * 1  1/200 (0.50%)  0/199 (0.00%)  1/196 (0.51%) 
Oesophageal Candidiasis * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Respiratory Tract Infection * 1  0/200 (0.00%)  1/199 (0.50%)  0/196 (0.00%) 
Upper Respiratory Tract Infection * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Investigations       
Blood Alkaline Phosphatase Increased * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Blood Bilirubin Increased * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Blood Pressure Increased * 1  1/200 (0.50%)  0/199 (0.00%)  0/196 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Musculoskeletal Pain * 1  1/200 (0.50%)  0/199 (0.00%)  2/196 (1.02%) 
Rheumatoid Arthritis * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Synovial Cyst * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Nervous system disorders       
Dizziness * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/200 (0.50%)  0/199 (0.00%)  0/196 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/200 (0.00%)  0/199 (0.00%)  1/196 (0.51%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01981473     History of Changes
Other Study ID Numbers: B1801364
ANTIBODY-RA ( Other Identifier: Alias Study Number )
First Submitted: November 5, 2013
First Posted: November 11, 2013
Results First Submitted: September 11, 2015
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016