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A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

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: NCT02198651
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Rheumatoid Arthritis
Musculoskeletal and Connective Tissue Diseases
Interventions Biological: Adalimumab
Other: Placebo
Enrollment 149
Recruitment Details  
Pre-assignment Details All Lead-in-Treated Subject population: participants who were enrolled in the study and received at least 1 dose of study drug during the Lead-in period. Three participants enrolled in the study but were not treated during the Lead-in period.
Arm/Group Title Adalimumab 40 mg Eow Adalimumab Tapering Adalimumab Withdrawal Arm Adalimumab Tapering to Rescue Arm Adalimumab Withdrawal to Rescue Arm
Hide Arm/Group Description 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period) 40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period) Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period) 40 mg adalimumab administered subcutaneously every other week (eow) from Flare Week 0 to Flare Week 16 (Open-Label Rescue Period) 40 mg adalimumab administered subcutaneously every other week (eow) from Flare Week 0 to Flare Week 16 (Open-Label Rescue Period)
Period Title: Lead-in Period
Started 149 0 0 0 0
Participants Treated in Lead-In Period 146 0 0 0 0
Completed 112 0 0 0 0
Not Completed 37 0 0 0 0
Reason Not Completed
Withdrew consent             13             0             0             0             0
Adverse Event             2             0             0             0             0
Other, not specified             22             0             0             0             0
Period Title: Double-blind Period
Started 0 102 20 0 0
Completed 0 93 19 0 0
Not Completed 0 9 1 0 0
Reason Not Completed
Withdrew consent             0             4             0             0             0
Adverse Event             0             1             0             0             0
Other, not specified             0             4             1             0             0
Period Title: Open-label Rescue Period
Started 0 0 0 31 8
Correctly Entered Open-label Rescue 0 0 0 30 8
Completed 0 0 0 28 8
Not Completed 0 0 0 3 0
Reason Not Completed
Withdrew consent             0             0             0             2             0
Incorrectly entered Open-label Rescue             0             0             0             1             0
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)
Overall Number of Baseline Participants 146
Hide Baseline Analysis Population Description
All Lead-in-Treated Subject population: participants who were enrolled in the study and received at least 1 dose of study drug during the Lead-in period
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants
59.6  (10.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Female 109
Male 37
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
American Indian or Alaska Native 0
Asian 2
Native Hawaiian or Other Pacific Islander 0
Black or African American 2
White 139
More than one race 0
Unknown or Not Reported 3
Tobacco Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Current 22
Former 46
Never 76
Unknown 2
Disease duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants
12.9  (9.99)
[1]
Measure Analysis Population Description: Participants with available data
Duration of adalimumab therapy  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants
5.4  (3.27)
Duration of remission   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants
2.2  (1.99)
[1]
Measure Analysis Population Description: Participants with available data
Previous treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Yes 145
No 1
Previous Tx with biological disease-modifying anti-rheumatic drugs (bDMARDs; excluding adalimumab)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Yes 38
No 108
Previous Tx with csDMARDS or bDMARDs (excluding adalimumab)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Yes 146
No 0
Participants' Global Assessment of Disease Activity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 146 participants
8.7  (11.84)
[1]
Measure Description: Participants rated the severity of their rheumatoid arthritis symptoms and how well they were doing during the last 24 hours by placing a vertical mark on a line with a range of 0 (very well) to 100 mm (very poorly).
Mean C-Reactive Protein (CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 146 participants
2.4  (2.58)
[1]
Measure Description: C-Reactive Protein (CRP; mg/L) was measured from blood samples as a marker for inflammation.
HAQ-DI Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 146 participants
0.4  (0.51)
[1]
Measure Description: The Health Assessment Questionnaire- Disability Index (HAQ-DI) is specific for rheumatoid arthritis. 20 questions refer to eight domains:dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants rated their ability to do each task over the past 7 days: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
1.Primary Outcome
Title Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm
Hide Description Synovitis was assessed in three wrist regions (the distal radioulnar joint; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each Metacarpophalangeal joint (MCP) joint. The first carpometacarpal joint and the first MCP joint are not scored. The scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline hand and wrist synovitis RAMRIS score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.
Time Frame From Week 4 to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
Arm/Group Title Adalimumab Tapering
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.993
(0.822 to 1.199)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab Tapering
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method Wald Chi
Comments [Not Specified]
2.Primary Outcome
Title Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm
Hide Description Bone marrow edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows-0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.
Time Frame From Week 4 to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
Arm/Group Title Adalimumab Tapering
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.959
(0.821 to 1.119)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab Tapering
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method Wald Chi
Comments [Not Specified]
3.Primary Outcome
Title Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm
Hide Description The composite score is the sum of the baseline hand and wrist synovitis and bone marrow edema RAMRIS scores. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between the composite baseline hand and wrist synovitis score and baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.
Time Frame From Week 4 to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
Arm/Group Title Adalimumab Tapering
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.979
(0.885 to 1.084)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab Tapering
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method Wald Chi
Comments [Not Specified]
4.Secondary Outcome
Title Median Time to Flare
Hide Description Time to flare was defined as the number of weeks from the date of the first dose of study drug in the Double-blind period to the date of flare.
Time Frame From Week 4 to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 102 20
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(36.4 to NA)
NA [1] 
(12.1 to NA)
[1]
NA = not estimable/calculable due to low number of events
5.Secondary Outcome
Title Physicians' Assessment of Flare Severity
Hide Description Physicians rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.
Time Frame At the Flare Week 0 Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
0 1 1
1 2 0
2 3 0
3 3 1
4 6 2
5 1 1
6 4 0
7 1 0
8 0 0
9 0 0
10 0 0
Missing 9 3
6.Secondary Outcome
Title Participants' Assessment of Flare Severity
Hide Description Participants rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.
Time Frame At the Flare Week 0 Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
0 1 0
1 2 1
2 2 2
3 3 0
4 4 0
5 1 1
6 4 1
7 1 0
8 2 0
9 0 0
10 2 0
Missing 8 3
7.Secondary Outcome
Title Percentage of Participants With a Flare
Hide Description Flare was defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR].
Time Frame From Week 4 to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 102 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.3
(27.0 to 46.4)
45.0
(23.1 to 68.5)
8.Secondary Outcome
Title Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time
Hide Description The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Clinical remission was defined as DAS28 (ESR) < 2.6.
Time Frame From Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All Open-label rescue-treated participants excluding those who incorrectly entered the Open-label Rescue Period; last observation carried forward
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
Flare Week 0 Number Analyzed 30 participants 8 participants
3 1
Flare Week 4 Number Analyzed 29 participants 7 participants
14 1
Flare Week 10 Number Analyzed 29 participants 7 participants
17 3
Flare Week 16 Number Analyzed 29 participants 8 participants
13 4
9.Secondary Outcome
Title Median Time to Clinical Remission From the Occurrence of Flare
Hide Description The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Clinical remission was defined as DAS28 (ESR) < 2.6. Time to clinical remission was defined as the number of weeks from the occurrence of flare to the first date of clinical remission.
Time Frame From Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All Open-label rescue treated participants excluding those who incorrectly entered the Open-label Rescue Period
Arm/Group Title Adalimumab Tapering Adalimumab Withdrawal Arm
Hide Arm/Group Description:
40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Overall Number of Participants Analyzed 30 8
Median (95% Confidence Interval)
Unit of Measure: weeks
6.1
(4.1 to 16.3)
18.0
(0.1 to 18.0)
10.Secondary Outcome
Title Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)
Hide Description The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
0.7  (1.27) 0.1  (0.46)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.1  (0.47) 0.1  (0.55)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
1.2  (1.34) 0.1  (0.39)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.9  (0.58) 0.0  (0.43)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
0.7  (1.18) -0.0  (0.53)
Double Blind Week 22- Withdrawal Arm Number Analyzed 4 participants 11 participants
0.5  (0.31) 0.1  (0.24)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
0.8  (1.16) 0.1  (0.50)
Double Blind Week 28- Withdrawal arm Number Analyzed 4 participants 11 participants
1.0  (1.54) 0.2  (0.25)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
0.7  (0.59) -0.0  (0.54)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-0.7  (0.11) -0.0  (0.46)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
1.5  (1.20) 0.0  (0.52)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.8  (2.18) 0.2  (0.38)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
2.3  (1.15)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
1.9  (0.96)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
1.3  (1.05)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
1.2  (1.14)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
0.9  (0.81)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.7  (0.50)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
1.2  (1.04)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.6  (0.80)
11.Secondary Outcome
Title Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 62 participants
4.4  (7.68) 0.6  (1.34)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
1.0  (2.45) 1.4  (2.85)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
7.0  (9.35) 0.4  (1.30)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
2.9  (2.42) -0.1  (0.88)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
3.2  (4.98) 0.3  (1.38)
Double Blind Week 22- Withdrawal Arm Number Analyzed 4 participants 11 participants
2.2  (1.93) 0.1  (0.73)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
3.7  (6.19) 0.5  (1.37)
Double Blind Week 28- Withdrawal arm Number Analyzed 4 participants 11 participants
6.3  (8.40) -0.1  (0.80)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
2.7  (3.04) 0.2  (1.08)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-0.1  (0.14) 0.0  (0.92)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
7.4  (10.04) 0.1  (1.33)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
7.7  (11.38) -0.3  (0.48)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
12.3  (9.56)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
9.4  (9.13)
Flare Week 4- Tapering Arm Number Analyzed 28 participants 0 participants
5.0  (6.55)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
5.4  (9.59)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
3.5  (4.55)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
3.6  (2.52)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
4.5  (6.14)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
2.8  (4.19)
12.Secondary Outcome
Title Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein levels (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 36 participants 62 participants
3.7  (8.57) 0.8  (1.85)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.9  (2.59) 1.3  (2.67)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
6.3  (10.25) 0.4  (1.35)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
3.6  (2.80) -0.1  (0.90)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
3.6  (5.18) 0.3  (1.47)
Double Blind Week 22- Withdrawal Arm Number Analyzed 4 participants 11 participants
2.3  (1.95) -0.0  (0.88)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
3.8  (6.34) 0.4  (1.37)
Double Blind Week 28- Withdrawal arm Number Analyzed 4 participants 11 participants
6.4  (8.40) 0.1  (1.61)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
3.0  (3.29) 0.2  (1.17)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.1  (0.33) 0.1  (1.07)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
7.5  (10.27) 0.1  (1.37)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
8.5  (10.23) -0.3  (0.62)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
11.6  (11.17)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
9.9  (8.31)
Flare Week 4- Tapering Arm Number Analyzed 28 participants 0 participants
4.1  (8.73)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
5.2  (9.64)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
2.5  (7.53)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
3.5  (2.51)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
3.6  (6.63)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
2.7  (4.20)
13.Secondary Outcome
Title Number of Participants Maintaining Clinical Remission Defined By DAS28 (ESR) < 2.6, SDAI ≤ 3.3, and CDAI ≤ 2.8 at Each Visit By Treatment Arm
Hide Description The maintenance of clinical remission after regaining remission during the Open-label rescue period was defined as either Disease Activity Score 28 (DAS28 ESR) < 2.6, Simplified Disease Activity Index (SDAI) score ≤ 3.3, or Clinical Disease Activity Index (CDAI) score ≤ 2.8).
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period; last observation carried forward
Arm/Group Title DAS28 (ESR) < 2.6 SDAI ≤ 3.3 CDAI ≤ 2.8
Hide Arm/Group Description:
Disease Activity Score 28 (DAS28 ESR) < 2.6
Simplified Disease Activity Index (SDAI) score ≤ 3.3
Clinical Disease Activity Index (CDAI) score ≤ 2.8
Overall Number of Participants Analyzed 122 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
Double Blind Baseline- Tapering Arm Number Analyzed 102 participants 102 participants 102 participants
102 89 85
Double Blind Baseline- Withdrawal Arm Number Analyzed 20 participants 20 participants 20 participants
20 19 19
Double Blind Week 10- Tapering Arm Number Analyzed 100 participants 98 participants 99 participants
85 63 62
Double Blind Week 10- Withdrawal Arm Number Analyzed 20 participants 20 participants 20 participants
18 16 14
Double Blind Week 16- Tapering Arm Number Analyzed 98 participants 98 participants 98 participants
78 64 62
Double Blind Week 16- Withdrawal arm Number Analyzed 20 participants 20 participants 20 participants
15 13 15
Double Blind Week 22- Tapering Arm Number Analyzed 82 participants 82 participants 82 participants
75 59 58
Double Blind Week 22- Withdrawal Arm Number Analyzed 15 participants 15 participants 15 participants
14 13 13
Double Blind Week 28- Tapering Arm Number Analyzed 79 participants 79 participants 79 participants
69 58 57
Double Blind Week 28- Withdrawal Arm Number Analyzed 15 participants 15 participants 15 participants
13 12 13
Double Blind Week 34- Tapering Arm Number Analyzed 75 participants 75 participants 75 participants
70 58 58
Double Blind Week 34- Withdrawal Arm Number Analyzed 13 participants 13 participants 13 participants
13 13 13
Double Blind Week 40- Tapering Arm Number Analyzed 74 participants 74 participants 74 participants
64 57 56
Double Blind Week 40- Withdrawal Arm Number Analyzed 13 participants 13 participants 13 participants
11 12 12
Flare Week 0- Tapering Arm Number Analyzed 31 participants 31 participants 31 participants
4 4 4
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 8 participants 8 participants
1 0 2
Flare Week 4- Tapering Arm Number Analyzed 29 participants 28 participants 28 participants
14 13 13
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 7 participants 7 participants
1 2 2
Flare Week 10- Tapering Arm Number Analyzed 29 participants 29 participants 29 participants
17 14 14
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 7 participants 7 participants
3 2 2
Flare Week 16- Tapering Arm Number Analyzed 29 participants 29 participants 29 participants
13 13 13
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 8 participants 8 participants
4 4 4
14.Secondary Outcome
Title Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score
Hide Description Synovitis was assessed in three wrist regions (the distal radioulnar joint; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each Metacarpophalangeal joint (MCP) joint. The first carpometacarpal joint and the first MCP joint are not scored. The scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment.
Time Frame From Week 4 to Week 40 or Final visit
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 45 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 40- Tapering Arm Number Analyzed 6 participants 51 participants
-0.1  (1.20) 0.1  (1.33)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 10 participants
0.0 -0.1  (0.90)
Flare Week 16- Tapering Arm Number Analyzed 25 participants 0 participants
0.8  (1.84)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.1  (1.81)
15.Secondary Outcome
Title Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score
Hide Description Bone edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows-0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%.
Time Frame From Week 4 to Week 40 or Final visit
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 40- Tapering Arm Number Analyzed 6 participants 52 participants
-0.5  (0.84) 0.0  (1.07)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 10 participants
0.0 1.2  (3.52)
Flare Week 16- Tapering Arm Number Analyzed 26 participants 0 participants
-0.1  (0.47)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.3  (0.38)
16.Secondary Outcome
Title Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score
Hide Description Bone erosions in each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) were scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the ''assessed bone volume'', judged on all available images-0: no erosion; 1: 1-10% of bone eroded; 2; 11-20%, etc.
Time Frame From Week 4 to Week 40 or Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 40- Tapering Arm Number Analyzed 6 participants 52 participants
-0.5  (1.73) 0.1  (0.52)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 10 participants
-2.0 0.0  (1.08)
Flare Week 16- Tapering Arm Number Analyzed 26 participants 0 participants
0.3  (1.02)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.1  (0.88)
17.Secondary Outcome
Title Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 30 participants 62 participants
0.1  (0.3) 0.0  (0.18)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.3  (0.61) 0.0  (0.17)
Double Blind Week 16- Tapering Arm Number Analyzed 19 participants 63 participants
0.2  (0.40) -0.0  (0.28)
Double Blind Week 16- Withdrawal Arm Number Analyzed 5 participants 11 participants
0.3  (0.54) -0.0  (0.12)
Double Blind Week 22- Tapering Arm Number Analyzed 15 participants 63 participants
0.1  (0.37) -0.0  (0.26)
Double Blind Week 22- Withdrawal Arm Number Analyzed 4 participants 11 participants
0.4  (0.79) 0.1  (0.39)
Double Blind Week 28- Tapering Arm Number Analyzed 12 participants 63 participants
0.2  (0.43) -0.0  (0.27)
Double Blind Week 28- Withdrawal Arm Number Analyzed 3 participants 11 participants
0.7  (0.69) -0.1  (0.15)
Double Blind Week 34- Tapering Arm Number Analyzed 11 participants 63 participants
0.3  (0.49) -0.0  (0.30)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.2  (0.27) 0.1  (0.17)
Double Blind Week 40- Tapering Arm Number Analyzed 7 participants 63 participants
0.4  (0.40) -0.1  (0.33)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 11 participants
1.9 0.0  (0.16)
Flare Week 0- Tapering Arm Number Analyzed 25 participants 0 participants
0.4  (0.57)
Flare Week 0- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.3  (0.29)
Flare Week 4- Tapering Arm Number Analyzed 27 participants 0 participants
0.2  (0.49)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.2  (0.35)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
0.1  (0.24)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.1  (0.20)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
0.2  (0.39)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.1  (0.24)
18.Secondary Outcome
Title Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The number of participants with HAQ-DI score ≤ 0.5 (considered to be normal) was recorded.
Time Frame Week 4 and Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Measure Type: Count of Participants
Unit of Measure: Participants
Double Blind Week 4- Tapering Arm Number Analyzed 37 participants 65 participants
21 50
Double Blind Week 4- Withdrawal Arm Number Analyzed 9 participants 11 participants
7 10
Double Blind Week 40- Tapering Arm Number Analyzed 7 participants 63 participants
2 48
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 11 participants
0 9
19.Secondary Outcome
Title Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits
Hide Description The RAPID3 is an activity index derived from the Multi-dimensional Health Assessment Questionnaire (MD-HAQ). It includes an assessment of physical function, a pain Visual Analog Scale (VAS), and a participant global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 30 where higher scores represent severe disease. Negative values indicate improvement from the Double-blind baseline score.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
1.9  (3.92) 0.7  (3.20)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
1.4  (3.73) 1.5  (4.67)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
4.7  (5.66) 0.8  (2.80)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
2.5  (4.59) 0.1  (1.37)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
2.6  (4.83) 0.3  (2.83)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
3.6  (4.18) 0.6  (3.31)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
2.2  (4.20) 0.6  (2.47)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
3.7  (4.45) -0.3  (1.61)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
2.2  (3.77) -0.0  (1.93)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
1.9  (2.62) 1.6  (2.33)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
4.7  (6.22) 0.0  (2.39)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.4  (0.92) 0.8  (1.62)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
6.1  (6.64)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
3.9  (5.60)
Flare Week 4- Tapering Arm Number Analyzed 27 participants 0 participants
3.1  (5.38)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
3.2  (4.15)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
2.8  (3.93)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
2.3  (2.61)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
2.9  (4.22)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
2.1  (3.01)
20.Secondary Outcome
Title Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home
Hide Description The RAPID3 is an activity index derived from the Multi-dimensional Health Assessment Questionnaire (MD-HAQ). It includes an assessment of physical function, a pain Visual Analog Scale (VAS), and a participant global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 30 where higher scores represent severe disease. Negative values indicate improvement from the Double-blind baseline score.
Time Frame Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15
Hide Outcome Measure Data
Hide Analysis Population Description
All Open-label rescue treated participants with available data; last observation carried forward
Arm/Group Title Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Flare Week 1- Tapering Arm Number Analyzed 19 participants
-1.6  (4.92)
Flare Week 1- Withdrawal Arm Number Analyzed 3 participants
3.7  (7.20)
Flare Week 2- Tapering Arm Number Analyzed 22 participants
-3.1  (5.41)
Flare Week 2- Withdrawal Arm Number Analyzed 4 participants
0.8  (6.89)
Flare Week 3- Tapering Arm Number Analyzed 25 participants
-3.8  (6.78)
Flare Week 3- Withdrawal Arm Number Analyzed 6 participants
-0.4  (7.94)
Flare Week 5- Tapering Arm Number Analyzed 26 participants
-3.8  (6.61)
Flare Week 5- Withdrawal Arm Number Analyzed 6 participants
-0.8  (6.56)
Flare Week 6- Tapering Arm Number Analyzed 26 participants
-4.1  (6.81)
Flare Week 6- Withdrawal Arm Number Analyzed 6 participants
-0.9  (6.97)
Flare Week 7- Tapering Arm Number Analyzed 26 participants
-3.7  (6.86)
Flare Week 7- Withdrawal Arm Number Analyzed 6 participants
-0.6  (6.26)
Flare Week 8- Tapering Arm Number Analyzed 27 participants
-4.4  (7.17)
Flare Week 8- Withdrawal Arm Number Analyzed 6 participants
-0.6  (5.56)
Flare Week 9- Tapering Arm Number Analyzed 27 participants
-3.3  (5.81)
Flare Week 9- Withdrawal Arm Number Analyzed 6 participants
-1.0  (5.89)
Flare Week 11- Tapering Arm Number Analyzed 27 participants
-3.7  (5.69)
Flare Week 11- Withdrawal Arm Number Analyzed 6 participants
-1.0  (5.85)
Flare Week 12- Tapering Arm Number Analyzed 27 participants
-3.4  (5.84)
Flare Week 12- Withdrawal Arm Number Analyzed 6 participants
-2.3  (4.46)
Flare Week 13- Tapering Arm Number Analyzed 27 participants
-3.5  (5.72)
Flare Week 13- Withdrawal Arm Number Analyzed 6 participants
-2.5  (4.78)
Flare Week 14- Tapering Arm Number Analyzed 27 participants
-3.1  (5.54)
Flare Week 14- Withdrawal Arm Number Analyzed 6 participants
-2.4  (4.79)
Flare Week 15- Tapering Arm Number Analyzed 27 participants
-3.5  (6.69)
Flare Week 15- Withdrawal Arm Number Analyzed 6 participants
-2.2  (4.70)
21.Secondary Outcome
Title Mean Change From Double-blind Baseline in Swollen Joint Count 28
Hide Description Twenty-eight joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 28 (worst possible score/28 joints with swelling). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: swollen joint counts
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 64 participants
0.9  (2.09) 0.1  (0.58)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.1  (0.33) -0.1  (0.30)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
1.2  (2.15) -0.0  (0.34)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.3  (0.50) 0.0  (0.45)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
0.6  (1.64) 0.1  (0.64)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
0.5  (0.58) -0.1  (0.30)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
0.5  (0.89) 0.0  (0.33)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
2.0  (2.45) -0.1  (0.30)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
0.0  (0.43) 0.0  (0.46)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) -0.1  (0.30)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
1.5  (3.01) 0.0  (0.42)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
2.0  (2.83) -0.1  (0.30)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
2.3  (2.60)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
1.9  (2.10)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
1.2  (1.98)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.6  (1.06)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
0.4  (0.89)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.1  (0.35)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
0.9  (1.81)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.3  (0.46)
22.Secondary Outcome
Title Mean Change From Double-blind Baseline in Swollen Joint Count 66
Hide Description Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: swollen joint counts
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 64 participants
1.1  (2.36) 0.1  (0.67)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.1  (0.33) -0.2  (0.40)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
1.4  (2.56) -0.0  (0.34)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.4  (0.53) 0.0  (0.45)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
0.6  (1.64) 0.1  (0.73)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
1.0  (1.41) -0.1  (0.30)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
0.5  (0.89) 0.1  (0.66)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
3.3  (4.72) -0.2  (0.40)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
0.0  (0.43) 0.0  (0.54)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) -0.2  (0.40)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
1.5  (3.01) 0.0  (0.46)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
2.0  (2.83) -0.2  (0.40)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
2.6  (2.90)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
2.6  (3.38)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
1.3  (1.99)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.6  (1.06)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
0.6  (1.10)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.4  (0.52)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
1.1  (2.21)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.4  (0.74)
23.Secondary Outcome
Title Mean Change From Double-blind Baseline in Tender Joint Count 28
Hide Description Twenty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 28 (worst possible score/28 joints with tenderness). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: tender joint counts
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 64 participants
1.3  (2.74) 0.1  (0.54)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
-0.1  (0.60) 0.5  (1.21)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
2.5  (4.49) 0.1  (0.41)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
1.0  (0.87) 0.0  (0.00)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
0.9  (1.66) -0.0  (0.42)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
0.8  (1.50) 0.1  (0.30)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
1.6  (3.39) 0.0  (0.51)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
1.8  (2.36) 0.2  (0.40)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
1.0  (1.65) -0.0  (0.42)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) 0.0  (0.00)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
2.0  (2.65) 0.0  (0.51)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
3.5  (4.95) 0.0  (0.00)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
4.4  (4.63)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
3.6  (3.81)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
1.5  (2.27)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
2.5  (5.13)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
0.9  (1.84)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
1.1  (1.46)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
1.8  (2.64)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
1.1  (1.89)
24.Secondary Outcome
Title Mean Change From Double-blind Baseline in Tender Joint Count 68
Hide Description Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: tender joint counts
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 64 participants
1.9  (3.45) 0.3  (1.47)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.1  (0.60) 0.9  (1.64)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
3.5  (6.33) 0.2  (1.36)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
1.4  (1.13) 0.2  (0.60)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
1.2  (2.27) 0.2  (1.35)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
2.0  (2.83) 0.4  (1.03)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
2.5  (5.34) 0.1  (0.96)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
3.8  (4.50) 0.3  (0.47)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
1.9  (2.87) 0.0  (0.73)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) 0.1  (0.30)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
3.0  (4.24) 0.0  (0.68)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
9.0  (12.73) -0.1  (0.30)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
6.2  (6.93)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
6.1  (6.27)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
1.9  (2.50)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
4.1  (8.48)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
1.5  (2.69)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
2.3  (2.31)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
2.1  (3.37)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
1.6  (1.85)
25.Secondary Outcome
Title Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity
Hide Description Participants rated the severity of their rheumatoid arthritis symptoms and how well they were doing during the last 24 hours by placing a vertical mark on a line with a range of 0 (very well) to 100 mm (very poorly). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
11.6  (19.00) 2.6  (8.49)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
8.0  (21.66) 9.6  (20.27)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
20.5  (26.97) 2.4  (9.27)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
10.7  (19.97) -0.3  (5.76)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
10.7  (17.74) 1.7  (9.14)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
5.8  (8.73) 0.2  (8.87)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
9.4  (21.03) 2.7  (10.03)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
15.0  (25.76) -1.0  (7.82)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
11.5  (13.70) 1.2  (7.23)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-1.0  (1.41) 0.7  (7.25)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
22.9  (35.32) 0.0  (7.60)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
2.0  (9.90) -1.7  (4.45)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
29.5  (29.43)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
21.6  (27.07)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
13.7  (22.93)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
11.7  (21.96)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
11.7  (16.89)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
14.1  (10.35)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
9.4  (13.47)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
6.9  (9.31)
26.Secondary Outcome
Title Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain
Hide Description Participants rated the severity of their rheumatoid arthritis pain in the past week by placing a vertical mark on a line with a range of 0 (no pain) to 100 mm (severe pain). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
8.0  (17.96) 3.5  (14.33)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
6.4  (19.05) 9.3  (21.04)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
17.8  (27.16) 3.0  (12.48)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
10.7  (18.93) -0.6  (9.65)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
10.4  (19.55) 0.3  (7.82)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
4.0  (4.90) -1.1  (11.20)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
8.3  (17.57) 1.6  (9.83)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
14.0  (24.59) -1.4  (10.93)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
11.6  (14.61) -0.3  (7.61)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-3.5  (2.12) 2.1  (8.40)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
24.0  (32.67) -0.5  (10.00)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-0.5  (20.51) -0.9  (5.07)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
24.4  (31.66)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
17.0  (19.38)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
9.0  (21.68)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
11.1  (17.46)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
7.5  (14.93)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
8.3  (9.60)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
8.0  (14.41)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
4.3  (6.32)
27.Secondary Outcome
Title Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity
Hide Description Physicians assessed participants' current rheumatoid arthritis disease activity at the time of the visit (independent of the participant's self-assessment) by placing a vertical mark on a line with a range of 0 (very low) to 100 mm (very high). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 62 participants
10.2  (19.54) 1.3  (4.27)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
1.6  (4.67) 0.5  (4.74)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
13.2  (21.48) 0.9  (5.07)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
5.0  (3.35) -0.5  (2.98)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
6.9  (14.83) 0.9  (5.05)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
3.8  (2.87) 0.4  (3.26)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
7.3  (16.51) 1.7  (5.51)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
10.0  (10.89) -0.9  (2.74)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
5.5  (12.27) 0.8  (3.60)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) 0.6  (4.13)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
16.2  (26.91) 1.0  (5.32)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
19.5  (26.16) -0.6  (2.42)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
26.5  (23.28)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
17.4  (15.37)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
12.2  (17.06)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
9.3  (20.27)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
10.2  (13.82)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
12.9  (11.51)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
8.6  (12.48)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
7.6  (20.00)
28.Secondary Outcome
Title Mean Change From Double-blind Baseline in Morning Stiffness Duration
Hide Description The duration of morning stiffness was reported by participants as the average daily length during the past week in minutes (from time of awaking to time of maximal improvement). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 45 74
Mean (Standard Deviation)
Unit of Measure: minutes
Double Blind Week 10- Tapering Arm Number Analyzed 36 participants 62 participants
3.5  (17.33) 1.8  (7.19)
Double Blind Week 10- Withdrawal Arm Number Analyzed 8 participants 10 participants
1.1  (3.60) 1.5  (5.97)
Double Blind Week 16- Tapering Arm Number Analyzed 34 participants 61 participants
6.6  (24.41) 2.3  (12.54)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
9.2  (19.78) -0.6  (5.05)
Double Blind Week 22- Tapering Arm Number Analyzed 18 participants 61 participants
-1.6  (8.07) 1.5  (9.67)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
1.0  (2.00) 0.5  (3.70)
Double Blind Week 28- Tapering arm Number Analyzed 15 participants 61 participants
2.6  (13.09) 2.4  (10.53)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
17.3  (28.81) 0.0  (3.71)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 61 participants
0.6  (10.97) 1.4  (8.86)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) -1.1  (6.64)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
2.0  (12.49) 0.4  (9.33)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (0.00) -0.2  (5.78)
Flare Week 0- Tapering Arm Number Analyzed 29 participants 0 participants
13.5  (25.21)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
18.5  (26.25)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
25.0  (110.77)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
19.9  (26.51)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
8.1  (30.20)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
7.9  (9.72)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
17.3  (36.46)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
9.6  (20.65)
29.Secondary Outcome
Title Mean Change From Double-blind Baseline in Morning Stiffness Severity
Hide Description Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
0.6  (1.51) 0.4  (1.01)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.4  (1.81) 0.6  (1.29)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
0.8  (1.73) 0.3  (1.11)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.7  (2.24) -0.1  (1.04)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
0.9  (1.27) 0.2  (0.85)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
0.8  (0.96) 0.4  (1.75)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
0.9  (1.69) 0.2  (1.10)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
1.3  (2.75) -0.2  (0.87)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
1.3  (1.71) 0.1  (0.85)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (1.41) -0.2  (1.08)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
1.8  (2.52) 0.1  (0.94)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-1.0  (1.41) -0.4  (1.03)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
1.6  (2.11)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
0.9  (1.96)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
0.8  (2.21)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.6  (1.72)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
0.6  (1.40)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.6  (1.27)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
0.6  (1.45)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
-0.1  (1.13)
30.Secondary Outcome
Title Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance
Hide Description Participants rated the severity of their sleep disturbance in the past week by placing a vertical mark on a line with a range of 0 (sleep is no problem) to 100 mm (sleep is a major problem). Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 63 participants
2.1  (15.37) 0.0  (8.99)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
-3.2  (29.39) 0.8  (1.54)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
10.2  (19.12) 1.7  (15.96)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
7.1  (22.42) 1.1  (3.02)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
8.2  (19.59) -0.3  (10.91)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
8.3  (31.35) 3.5  (8.70)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
1.8  (27.81) 2.1  (12.67)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
4.5  (19.82) -1.0  (7.63)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
5.6  (22.99) -0.4  (11.48)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-0.5  (30.41) -0.4  (2.77)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
17.7  (34.04) -0.2  (12.40)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-8.0  (15.56) -1.0  (4.43)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
18.9  (26.53)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
4.0  (14.61)
Flare Week 4- Tapering Arm Number Analyzed 29 participants 0 participants
4.9  (24.33)
Flare Week 4- Withdrawal Arm Number Analyzed 7 participants 0 participants
1.6  (10.05)
Flare Week 10- Tapering Arm Number Analyzed 29 participants 0 participants
0.2  (21.26)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
3.9  (12.98)
Flare Week 16- Tapering Arm Number Analyzed 29 participants 0 participants
2.3  (20.17)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
-7.3  (14.14)
31.Secondary Outcome
Title Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score
Hide Description Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.
Time Frame At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 61 participants
-8.3  (35.30) 0.2  (23.74)
Double Blind Week 16- Withdrawal Arm Number Analyzed 8 participants 11 participants
2.8  (39.51) -13.6  (43.84)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 61 participants
-10.1  (24.28) -3.8  (17.82)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
-5.6  (45.59) -17.2  (30.48)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
-15.2  (33.53) -4.4  (27.82)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-19.4  (27.50) -16.2  (45.10)
Flare Week 0- Tapering Arm Number Analyzed 28 participants 0 participants
-10.9  (39.82)
Flare Week 0- Withdrawal Arm Number Analyzed 7 participants 0 participants
-9.5  (38.05)
Flare Week 4- Tapering Arm Number Analyzed 25 participants 0 participants
-17.3  (40.07)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
-6.5  (48.23)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
-10.7  (44.07)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
7.9  (34.23)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-7.5  (25.49)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
-16.7  (39.67)
32.Secondary Outcome
Title Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score
Hide Description Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.
Time Frame At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 61 participants
-8.0  (17.25) -0.5  (11.26)
Double Blind Week 16- Withdrawal Arm Number Analyzed 8 participants 11 participants
9.4  (20.04) 2.8  (9.42)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 61 participants
-2.7  (12.28) 1.1  (7.44)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
14.1  (28.13) 2.8  (9.42)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
-2.3  (14.86) 1.1  (11.61)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
28.1  (39.77) 2.8  (9.42)
Flare Week 0- Tapering Arm Number Analyzed 28 participants 0 participants
-5.1  (15.96)
Flare Week 0- Withdrawal Arm Number Analyzed 7 participants 0 participants
2.7  (7.09)
Flare Week 4- Tapering Arm Number Analyzed 25 participants 0 participants
-5.0  (19.52)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
3.1  (7.65)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
-3.7  (13.90)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
2.7  (7.09)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-2.0  (6.60)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
2.7  (7.09)
33.Secondary Outcome
Title Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score
Hide Description Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.
Time Frame At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 61 participants
-0.2  (16.96) 0.8  (13.45)
Double Blind Week 16- Withdrawal Arm Number Analyzed 8 participants 11 participants
-4.9  (19.57) 4.0  (10.86)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 61 participants
0.0  (18.70) -1.0  (15.47)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
-4.2  (12.32) -3.5  (13.21)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
-4.0  (9.65) -0.1  (16.50)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-16.7  (23.57) 2.5  (18.32)
Flare Week 0- Tapering Arm Number Analyzed 28 participants 0 participants
4.2  (12.53)
Flare Week 0- Withdrawal Arm Number Analyzed 7 participants 0 participants
-7.1  (14.60)
Flare Week 4- Tapering Arm Number Analyzed 25 participants 0 participants
4.4  (19.84)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
5.6  (18.92)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
1.2  (10.60)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.8  (16.49)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
1.6  (19.65)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.8  (20.89)
34.Secondary Outcome
Title Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score
Hide Description Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.
Time Frame At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 61 participants
-11.6  (24.99) -3.4  (17.91)
Double Blind Week 16- Withdrawal Arm Number Analyzed 8 participants 11 participants
-2.7  (15.24) 0.6  (22.69)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 61 participants
-2.2  (12.70) -5.7  (14.97)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
5.4  (15.84) -4.5  (25.81)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
-3.2  (13.31) -2.6  (15.10)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
0.0  (10.10) -3.2  (21.98)
Flare Week 0- Tapering Arm Number Analyzed 28 participants 0 participants
-11.7  (27.58)
Flare Week 0- Withdrawal Arm Number Analyzed 7 participants 0 participants
-9.2  (25.66)
Flare Week 4- Tapering Arm Number Analyzed 25 participants 0 participants
-3.1  (20.32)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
-1.2  (24.08)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
-0.8  (13.77)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
-2.0  (18.77)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-6.6  (24.20)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
-8.2  (16.72)
35.Secondary Outcome
Title Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores
Hide Description The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in rheumatoid arthritis consisting of 6 questions, based on participant recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.
Time Frame At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 75
Mean (Standard Deviation)
Unit of Measure: percent impairment
Overall Work Impairment at Week 28- Tapering Arm Number Analyzed 2 participants 27 participants
15.0  (21.21) 3.5  (10.68)
Overall Work Impairment at Week 28- Withdrawal Arm Number Analyzed 1 participants 5 participants
0.0 0.6  (8.12)
Activity Impairment at Week 28- Tapering arm Number Analyzed 14 participants 61 participants
5.0  (19.51) 2.8  (13.43)
Activity Impairment at Week 28- Withdrawal Arm Number Analyzed 3 participants 11 participants
10.0  (17.32) -0.9  (7.01)
Overall Work Impairment at Week 40- Tapering Arm Number Analyzed 0 participants 28 participants
3.4  (18.78)
Overall Work Impairment at Week 40- Withdrawal Arm Number Analyzed 0 participants 5 participants
0.6  (8.12)
Activity Impairment at Week 40- Tapering arm Number Analyzed 7 participants 61 participants
15.7  (9.76) 0.5  (13.59)
Activity Impairment at Week 40- Withdrawal Arm Number Analyzed 1 participants 11 participants
20.0 0.0  (6.32)
Overall Work Impairment Flare Wk 0- Tapering Arm Number Analyzed 5 participants 0 participants
14.0  (27.02)
Overall Work Impairment Flare Wk 0- Withdrawal Arm Number Analyzed 2 participants 0 participants
5.0  (7.07)
Activity Impairment Flare Week 0- Tapering Arm Number Analyzed 22 participants 0 participants
25.9  (31.57)
Activity Impairment Flare Week 0- Withdrawal Arm Number Analyzed 5 participants 0 participants
8.0  (25.88)
Overall Work Impairment Flare Wk 10- Tapering Arm Number Analyzed 8 participants 0 participants
-0.2  (8.78)
Overall Work Impairment Flare W 10- Withdrawal Arm Number Analyzed 2 participants 0 participants
5.0  (7.07)
Activity Impairment Flare Wk 10- Tapering Arm Number Analyzed 26 participants 0 participants
6.5  (15.48)
Activity Impairment Flare W 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
12.9  (13.80)
Overall Work Impairment Flare Wk 16- Tapering Arm Number Analyzed 8 participants 0 participants
10.0  (14.82)
Overall Work Impairment Flare W 16- Withdrawal Arm Number Analyzed 3 participants 0 participants
10.0  (10.00)
Activity Impairment Flare Wk 16- Tapering Arm Number Analyzed 29 participants 0 participants
11.0  (17.39)
Activity Impairment Flare Wk 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
8.8  (11.26)
36.Secondary Outcome
Title Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score
Hide Description The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.
Time Frame At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 45 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 28- Tapering arm Number Analyzed 13 participants 60 participants
-2.9  (7.53) -1.1  (4.18)
Double Blind Week 28- Withdrawal Arm Number Analyzed 3 participants 11 participants
-1.9  (7.39) -2.4  (3.97)
Double Blind Week 40- Tapering Arm Number Analyzed 6 participants 60 participants
-5.5  (6.42) -0.4  (5.53)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 11 participants
-1.6 -2.1  (5.22)
Flare Week 0- Tapering Arm Number Analyzed 22 participants 0 participants
-10.8  (10.85)
Flare Week 0- Withdrawal Arm Number Analyzed 5 participants 0 participants
-2.4  (10.81)
Flare Week 4- Tapering Arm Number Analyzed 24 participants 0 participants
-5.2  (8.37)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
-8.0  (7.35)
Flare Week 10- Tapering Arm Number Analyzed 25 participants 0 participants
-4.0  (7.22)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
-4.0  (4.57)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-3.8  (7.38)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
-2.5  (2.80)
37.Secondary Outcome
Title Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score
Hide Description The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.
Time Frame At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 45 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 28- Tapering arm Number Analyzed 13 participants 60 participants
-5.5  (11.31) -0.8  (6.02)
Double Blind Week 28- Withdrawal Arm Number Analyzed 3 participants 11 participants
-5.2  (5.90) -0.1  (7.20)
Double Blind Week 40- Tapering Arm Number Analyzed 6 participants 60 participants
-3.5  (11.14) -0.8  (5.89)
Double Blind Week 40- Withdrawal Arm Number Analyzed 1 participants 11 participants
-8.5 -0.4  (6.71)
Flare Week 0- Tapering Arm Number Analyzed 22 participants 0 participants
-4.1  (11.43)
Flare Week 0- Withdrawal Arm Number Analyzed 5 participants 0 participants
0.4  (4.59)
Flare Week 4- Tapering Arm Number Analyzed 24 participants 0 participants
-2.0  (5.95)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
-0.5  (2.51)
Flare Week 10- Tapering Arm Number Analyzed 25 participants 0 participants
-1.1  (10.14)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
-0.4  (3.06)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-4.0  (11.01)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
0.1  (2.55)
38.Secondary Outcome
Title Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Hide Description The FACIT-Fatigue questionnaire is a participant questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A negative change from baseline indicates worsening.
Time Frame At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 61 participants
-6.0  (9.80) -1.5  (5.42)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
-2.3  (3.39) -1.9  (3.27)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 61 participants
-3.5  (7.58) -1.6  (5.60)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
-4.3  (7.23) -2.2  (4.67)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 61 participants
-6.4  (8.44) -0.4  (4.00)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-2.5  (6.36) -1.5  (4.78)
Flare Week 0- Tapering Arm Number Analyzed 28 participants 0 participants
-7.4  (11.17)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
-3.6  (4.75)
Flare Week 4- Tapering Arm Number Analyzed 25 participants 0 participants
-3.8  (9.19)
Flare Week 4- Withdrawal Arm Number Analyzed 6 participants 0 participants
-4.7  (5.43)
Flare Week 10- Tapering Arm Number Analyzed 27 participants 0 participants
-3.9  (8.44)
Flare Week 10- Withdrawal Arm Number Analyzed 7 participants 0 participants
-2.4  (4.47)
Flare Week 16- Tapering Arm Number Analyzed 28 participants 0 participants
-4.5  (9.01)
Flare Week 16- Withdrawal Arm Number Analyzed 7 participants 0 participants
-1.7  (1.89)
39.Secondary Outcome
Title Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)
Hide Description C-Reactive Protein (CRP; mg/L) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: mg/L
Double Blind Week 10- Tapering Arm Number Analyzed 36 participants 64 participants
-7.9  (48.87) 1.7  (12.92)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
-0.2  (3.55) -0.6  (2.53)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
-7.4  (49.77) -0.4  (4.26)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
6.6  (12.26) -0.1  (3.67)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
3.6  (9.69) -0.0  (5.43)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
0.6  (0.37) -0.9  (3.38)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
0.5  (3.85) -0.4  (4.65)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
1.1  (1.34) 2.5  (11.60)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
3.2  (10.13) -0.4  (4.41)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
1.8  (1.89) 0.3  (5.98)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
1.0  (5.69) -0.3  (4.18)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
8.3  (11.60) -0.1  (3.43)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
-7.4  (54.12)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
5.4  (12.67)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
-8.5  (55.47)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
-1.3  (4.01)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
-9.5  (55.61)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
-0.6  (0.97)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
-9.1  (53.70)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
-0.8  (2.74)
40.Secondary Outcome
Title Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)
Hide Description Erythrocyte sedimentation rate (ESR; mm/hour) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. Negative values indicate improvement from baseline.
Time Frame From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint
Arm/Group Title Flared Participants Non-Flared Participants
Hide Arm/Group Description:
Participants who experienced flare during the Double-blind Period
Participants who did not experience flare during the Double-blind Period
Overall Number of Participants Analyzed 46 76
Mean (Standard Deviation)
Unit of Measure: mm/hour
Double Blind Week 10- Tapering Arm Number Analyzed 37 participants 64 participants
4.1  (11.25) 0.7  (5.22)
Double Blind Week 10- Withdrawal Arm Number Analyzed 9 participants 11 participants
0.9  (9.24) -1.5  (5.43)
Double Blind Week 16- Tapering Arm Number Analyzed 35 participants 63 participants
4.6  (10.73) 0.5  (5.82)
Double Blind Week 16- Withdrawal Arm Number Analyzed 9 participants 11 participants
5.2  (15.23) -0.3  (5.31)
Double Blind Week 22- Tapering Arm Number Analyzed 19 participants 63 participants
3.5  (10.73) -0.5  (7.38)
Double Blind Week 22- Withdrawal arm Number Analyzed 4 participants 11 participants
2.8  (9.22) -0.3  (4.22)
Double Blind Week 28- Tapering arm Number Analyzed 16 participants 63 participants
3.4  (8.18) 0.4  (6.93)
Double Blind Week 28- Withdrawal Arm Number Analyzed 4 participants 11 participants
6.0  (10.10) 1.0  (5.04)
Double Blind Week 34- Tapering Arm Number Analyzed 12 participants 63 participants
4.8  (7.28) 0.3  (7.57)
Double Blind Week 34- Withdrawal Arm Number Analyzed 2 participants 11 participants
-5.0  (1.41) -0.5  (5.94)
Double Blind Week 40- Tapering Arm Number Analyzed 11 participants 63 participants
10.2  (13.22) 1.4  (7.19)
Double Blind Week 40- Withdrawal Arm Number Analyzed 2 participants 11 participants
-2.0  (5.66) 4.7  (8.89)
Flare Week 0- Tapering Arm Number Analyzed 30 participants 0 participants
10.4  (12.50)
Flare Week 0- Withdrawal Arm Number Analyzed 8 participants 0 participants
13.0  (11.90)
Flare Week 4- Tapering Arm Number Analyzed 30 participants 0 participants
7.2  (9.82)
Flare Week 4- Withdrawal Arm Number Analyzed 8 participants 0 participants
8.5  (9.52)
Flare Week 10- Tapering Arm Number Analyzed 30 participants 0 participants
5.8  (10.16)
Flare Week 10- Withdrawal Arm Number Analyzed 8 participants 0 participants
4.4  (6.91)
Flare Week 16- Tapering Arm Number Analyzed 30 participants 0 participants
8.0  (10.95)
Flare Week 16- Withdrawal Arm Number Analyzed 8 participants 0 participants
7.0  (14.40)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug in the Double-blind Period (up to 50 weeks); for participants who experienced flare during the double-blind period, AEs were collected until 70 days after the last dose of study drug in the 16-week Open-label Rescue Period (up to 66 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Adalimumab 40 mg Eow Adalimumab Tapering Adalimumab Withdrawal Arm Adalimumab 40 mg Eow Rescue Arm
Hide Arm/Group Description 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period) Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period) 40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)
All-Cause Mortality
Adalimumab 40 mg Eow Adalimumab Tapering Adalimumab Withdrawal Arm Adalimumab 40 mg Eow Rescue Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)      0/102 (0.00%)      0/20 (0.00%)      0/39 (0.00%)    
Hide Serious Adverse Events
Adalimumab 40 mg Eow Adalimumab Tapering Adalimumab Withdrawal Arm Adalimumab 40 mg Eow Rescue Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/146 (2.74%)      1/102 (0.98%)      0/20 (0.00%)      3/39 (7.69%)    
Cardiac disorders         
ATRIAL FIBRILLATION  1  1/146 (0.68%)  1 0/102 (0.00%)  0 0/20 (0.00%)  0 0/39 (0.00%)  0
Eye disorders         
RETINAL VEIN OCCLUSION  1  0/146 (0.00%)  0 0/102 (0.00%)  0 0/20 (0.00%)  0 1/39 (2.56%)  1
Infections and infestations         
PNEUMONIA  1  1/146 (0.68%)  1 0/102 (0.00%)  0 0/20 (0.00%)  0 0/39 (0.00%)  0
Injury, poisoning and procedural complications         
COMMINUTED FRACTURE  1  1/146 (0.68%)  1 0/102 (0.00%)  0 0/20 (0.00%)  0 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders         
OSTEOARTHRITIS  1  0/146 (0.00%)  0 0/102 (0.00%)  0 0/20 (0.00%)  0 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BREAST CANCER  1  0/146 (0.00%)  0 1/102 (0.98%)  1 0/20 (0.00%)  0 0/39 (0.00%)  0
Nervous system disorders         
TRANSIENT ISCHAEMIC ATTACK  1  1/146 (0.68%)  1 0/102 (0.00%)  0 0/20 (0.00%)  0 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
PLEURAL EFFUSION  1  0/146 (0.00%)  0 0/102 (0.00%)  0 0/20 (0.00%)  0 1/39 (2.56%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab 40 mg Eow Adalimumab Tapering Adalimumab Withdrawal Arm Adalimumab 40 mg Eow Rescue Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/146 (7.53%)      33/102 (32.35%)      12/20 (60.00%)      13/39 (33.33%)    
General disorders         
OEDEMA PERIPHERAL  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 1/39 (2.56%)  1
Infections and infestations         
INFLUENZA  1  0/146 (0.00%)  0 5/102 (4.90%)  6 2/20 (10.00%)  2 0/39 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  1/146 (0.68%)  1 3/102 (2.94%)  3 1/20 (5.00%)  1 1/39 (2.56%)  1
NASOPHARYNGITIS  1  4/146 (2.74%)  4 16/102 (15.69%)  17 4/20 (20.00%)  5 4/39 (10.26%)  4
PHARYNGOTONSILLITIS  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
TONSILLITIS  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
TOOTH INFECTION  1  1/146 (0.68%)  1 0/102 (0.00%)  0 1/20 (5.00%)  1 1/39 (2.56%)  1
UPPER RESPIRATORY TRACT INFECTION  1  0/146 (0.00%)  0 1/102 (0.98%)  1 0/20 (0.00%)  0 3/39 (7.69%)  3
URINARY TRACT INFECTION  1  2/146 (1.37%)  2 0/102 (0.00%)  0 0/20 (0.00%)  0 2/39 (5.13%)  2
Injury, poisoning and procedural complications         
LIMB INJURY  1  0/146 (0.00%)  0 0/102 (0.00%)  0 2/20 (10.00%)  2 1/39 (2.56%)  1
MUSCLE STRAIN  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
Investigations         
C-REACTIVE PROTEIN INCREASED  1  0/146 (0.00%)  0 1/102 (0.98%)  1 1/20 (5.00%)  1 0/39 (0.00%)  0
HEPATIC ENZYME INCREASED  1  0/146 (0.00%)  0 0/102 (0.00%)  0 0/20 (0.00%)  0 2/39 (5.13%)  2
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  0/146 (0.00%)  0 6/102 (5.88%)  10 0/20 (0.00%)  0 1/39 (2.56%)  1
BACK PAIN  1  0/146 (0.00%)  0 1/102 (0.98%)  1 1/20 (5.00%)  1 0/39 (0.00%)  0
MUSCULOSKELETAL STIFFNESS  1  0/146 (0.00%)  0 1/102 (0.98%)  1 1/20 (5.00%)  1 0/39 (0.00%)  0
NECK PAIN  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
OSTEOPOROSIS  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
PAIN IN EXTREMITY  1  0/146 (0.00%)  0 1/102 (0.98%)  1 1/20 (5.00%)  1 0/39 (0.00%)  0
RHEUMATOID ARTHRITIS  1  0/146 (0.00%)  0 5/102 (4.90%)  5 1/20 (5.00%)  1 0/39 (0.00%)  0
Renal and urinary disorders         
URINARY RETENTION  1  0/146 (0.00%)  0 0/102 (0.00%)  0 1/20 (5.00%)  1 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
COUGH  1  4/146 (2.74%)  4 4/102 (3.92%)  4 1/20 (5.00%)  1 0/39 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02198651    
Other Study ID Numbers: M14-500
2014-001114-26 ( EudraCT Number )
First Submitted: July 22, 2014
First Posted: July 24, 2014
Results First Submitted: April 29, 2019
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019