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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02198651
Registration number
NCT02198651
Ethics application status
Date submitted
22/07/2014
Date registered
24/07/2014
Date last updated
25/06/2019
Titles & IDs
Public title
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
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Scientific title
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)
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Secondary ID [1]
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2014-001114-26
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Secondary ID [2]
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M14-500
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Universal Trial Number (UTN)
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Trial acronym
PREDICTRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Musculoskeletal and Connective Tissue Diseases
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Adalimumab
Other interventions - Placebo
Experimental: Adalimumab 40 mg eow - 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)
Active Comparator: Adalimumab Tapering - 40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Placebo Comparator: Adalimumab Withdrawal Arm - Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
Experimental: Adalimumab 40 mg eow Rescue Arm - 40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)
Other interventions: Adalimumab
Pre-filled syringe, administered by subcutaneous injection
Other interventions: Placebo
Pre-filled syringe, administered by subcutaneous injection in the Double-blind period
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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From Week 4 to Week 40
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Primary outcome [2]
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Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm
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Assessment method [2]
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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.
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Timepoint [2]
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From Week 4 to Week 40
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Primary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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From Week 4 to Week 40
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Secondary outcome [1]
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Median Time to Flare
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Assessment method [1]
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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.
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Timepoint [1]
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From Week 4 to Week 40
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Secondary outcome [2]
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Physicians' Assessment of Flare Severity
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Assessment method [2]
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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.
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Timepoint [2]
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At the Flare Week 0 Visit
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Secondary outcome [3]
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Participants' Assessment of Flare Severity
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Assessment method [3]
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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.
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Timepoint [3]
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At the Flare Week 0 Visit
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Secondary outcome [4]
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Percentage of Participants With a Flare
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Assessment method [4]
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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].
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Timepoint [4]
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From Week 4 to Week 40
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Secondary outcome [5]
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Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time
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Assessment method [5]
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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.
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Timepoint [5]
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From Flare Week 0 to Flare Week 16
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Secondary outcome [6]
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Median Time to Clinical Remission From the Occurrence of Flare
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Assessment method [6]
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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.
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Timepoint [6]
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From Flare Week 0 to Flare Week 16
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Secondary outcome [7]
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Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)
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Assessment method [7]
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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.
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Timepoint [7]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [8]
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Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score
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Assessment method [8]
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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.
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Timepoint [8]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [9]
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Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score
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Assessment method [9]
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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.
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Timepoint [9]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [10]
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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
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Assessment method [10]
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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).
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Timepoint [10]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [11]
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Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score
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Assessment method [11]
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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.
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Timepoint [11]
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From Week 4 to Week 40 or Final visit
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Secondary outcome [12]
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Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score
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Assessment method [12]
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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%.
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Timepoint [12]
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From Week 4 to Week 40 or Final visit
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Secondary outcome [13]
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Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score
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Assessment method [13]
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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.
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Timepoint [13]
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From Week 4 to Week 40 or Final Visit
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Secondary outcome [14]
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Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time
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Assessment method [14]
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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.
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Timepoint [14]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [15]
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Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score = 0.5 at Double-blind Baseline and at Week 40
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Assessment method [15]
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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.
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Timepoint [15]
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Week 4 and Week 40
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Secondary outcome [16]
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Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits
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Assessment method [16]
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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.
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Timepoint [16]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [17]
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Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home
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Assessment method [17]
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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.
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Timepoint [17]
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Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15
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Secondary outcome [18]
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Mean Change From Double-blind Baseline in Swollen Joint Count 28
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Assessment method [18]
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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.
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Timepoint [18]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [19]
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Mean Change From Double-blind Baseline in Swollen Joint Count 66
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Assessment method [19]
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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.
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Timepoint [19]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [20]
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Mean Change From Double-blind Baseline in Tender Joint Count 28
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Assessment method [20]
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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.
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Timepoint [20]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [21]
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Mean Change From Double-blind Baseline in Tender Joint Count 68
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Assessment method [21]
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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.
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Timepoint [21]
0
0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [22]
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Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity
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Assessment method [22]
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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.
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Timepoint [22]
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0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [23]
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Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain
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Assessment method [23]
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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.
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Timepoint [23]
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From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [24]
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Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity
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Assessment method [24]
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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.
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Timepoint [24]
0
0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [25]
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Mean Change From Double-blind Baseline in Morning Stiffness Duration
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Assessment method [25]
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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.
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Timepoint [25]
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0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [26]
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Mean Change From Double-blind Baseline in Morning Stiffness Severity
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Assessment method [26]
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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.
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Timepoint [26]
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0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [27]
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Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance
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Assessment method [27]
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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.
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Timepoint [27]
0
0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [28]
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0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score
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Assessment method [28]
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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.
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Timepoint [28]
0
0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [29]
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0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score
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Assessment method [29]
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0
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.
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Timepoint [29]
0
0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [30]
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0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score
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Assessment method [30]
0
0
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.
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Timepoint [30]
0
0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [31]
0
0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score
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Assessment method [31]
0
0
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.
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Timepoint [31]
0
0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [32]
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Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores
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Assessment method [32]
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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.
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Timepoint [32]
0
0
At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16
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Secondary outcome [33]
0
0
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score
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Assessment method [33]
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0
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.
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Timepoint [33]
0
0
At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [34]
0
0
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score
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Assessment method [34]
0
0
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.
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Timepoint [34]
0
0
At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [35]
0
0
Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
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Assessment method [35]
0
0
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.
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Timepoint [35]
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0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [36]
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0
Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)
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Assessment method [36]
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0
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.
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Timepoint [36]
0
0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Secondary outcome [37]
0
0
Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)
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Assessment method [37]
0
0
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.
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Timepoint [37]
0
0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
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Eligibility
Key inclusion criteria
1. Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987
revised American College of Rheumatology (ACR) classification criteria and/or the ACR
/European League Against Rheumatism (EULAR) 2010 classification criteria (any duration
since diagnosis).
2. Participant must have met the following criteria:
- Must have been treated with adalimumab 40 mg subcutaneously every other week (sc
eow) for at least 12 months prior to Week 0 Visit
- Must have been treated with concomitant methotrexate (MTX) at a stable dose
(oral, sc or intramuscular (im) at any dose) for at least 12 weeks prior to Week
0 Visit or if not on MTX, must have been treated with other allowed conventional
synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at a stable dose for
at least 12 weeks prior to Week 0 Visit or if not treated with csDMARDs must
maintain this regimen for at least 12 weeks prior to Week 0 Visit.
3. Participant must be in sustained clinical remission based on the following:
- At least one documented 4 or 3 (if Patient's Global Assessment ; PGA is not
available) variables Disease Activity Score 28 Erythrocyte sedimentation rate
(DAS28 ESR) or DAS28 C-reactive protein (CRP) < 2.6 (or calculated based on
documented components of the DAS28) in the participant's chart 6 months or longer
prior to the Screening Visit;
- 4 variables DAS28 (ESR) assessed at Screening < 2.6, with all components
including ESR assessed at Screening.
4. If participant was receiving concomitant allowed csDMARDs (in addition or not to MTX)
the dose must have been stable for at least 12 weeks prior to the Week 0 Visit (e.g.,
chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including
auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
5. If participant was receiving concomitant oral corticosteroids, prednisone or
equivalent must have been < 10 mg/day and the dose must have been stable for at least
4 weeks prior to the Week 0 Visit.
6. If participant was receiving concomitant non-steroidal anti-inflammatory drugs
(NSAIDs), tramadol or other equivalent opioids and/or non-opioid analgesics, the dose
and/or therapeutic scheme must have been stable for at least 4 weeks prior to the Week
0 Visit.
7. Participant must have been able and willing to provide written informed consent and
comply with the requirements of this study protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any 4 or 3 (if PGA is not available) variables DAS28 (ESR) or DAS28 (CRP) (or
calculated based on documented components of the DAS28) assessed within 6 months prior
to the Screening Visit = 2.6.
2. Participant was on an additional concomitant biological disease-modifying
anti-rheumatic drug (bDMARD) (including but not limited to abatacept, anakinra,
certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
3. Participant had been treated with intra-articular or parenteral corticosteroids within
the last four weeks before Screening.
4. Participant had undergone joint surgery within 12 weeks of Screening (at joints to be
assessed by magnetic resonance imaging (MRI) and/or ultrasound).
5. Participant had a medical condition precluding an MRI (e.g. magnetic activated
implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and
metallic devices or fragments or clips in the eye, brain or spinal canal and in the
hand/wrist undergoing MRI)
6. Participant had a medical condition precluding a contrast MRI with gadolinium [e.g.
nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to
gadolinium containing contrast agent, pregnancy or breast feeding, severe renal
insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 30
mL/min/1.73m^2 at Screening, hepato-renal syndrome, severe chronic liver function
impairment]
7. Participant had been treated with any investigational drug of chemical or biologic
nature within a minimum of 30 days or five half-lives (whichever is longer) of the
drug prior to the Screening Visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2018
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Sample size
Target
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Accrual to date
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Final
149
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital /ID# 154649 - Camperdown
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Recruitment hospital [2]
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0
Optimus Clinical Research Pty. /ID# 133881 - Kogarah
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Recruitment hospital [3]
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0
John Hunter Hospital /ID# 133884 - Newcastle
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Recruitment hospital [4]
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0
Rheumatology Research Unit /ID# 133883 - Maroochydore
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Recruitment postcode(s) [1]
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0
2050 - Camperdown
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Recruitment postcode(s) [2]
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0
2217 - Kogarah
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Recruitment postcode(s) [3]
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0
2305 - Newcastle
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Recruitment postcode(s) [4]
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0
4558 - Maroochydore
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Louisiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Mississippi
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Country [8]
0
0
United States of America
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State/province [8]
0
0
New York
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Country [9]
0
0
United States of America
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State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Pennsylvania
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Country [11]
0
0
United States of America
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State/province [11]
0
0
South Carolina
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
Austria
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State/province [14]
0
0
Wien
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Country [15]
0
0
Canada
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State/province [15]
0
0
Ontario
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Country [16]
0
0
Canada
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State/province [16]
0
0
Quebec
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Country [17]
0
0
France
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State/province [17]
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0
Poitou-Charentes
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Country [18]
0
0
France
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State/province [18]
0
0
Somme
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Country [19]
0
0
France
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State/province [19]
0
0
Chartres
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Country [20]
0
0
France
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State/province [20]
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0
Grenoble
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Country [21]
0
0
Germany
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State/province [21]
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0
Bad Abbach
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Country [22]
0
0
Germany
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State/province [22]
0
0
Berlin-buch
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Country [23]
0
0
Germany
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State/province [23]
0
0
Berlin
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Country [24]
0
0
Germany
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State/province [24]
0
0
Cologne
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Country [25]
0
0
Germany
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State/province [25]
0
0
Hamburg
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Country [26]
0
0
Germany
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State/province [26]
0
0
Munich
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Country [27]
0
0
Germany
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State/province [27]
0
0
Ratingen
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Country [28]
0
0
Germany
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State/province [28]
0
0
Rendsburg
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Country [29]
0
0
Greece
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State/province [29]
0
0
Attiki
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Country [30]
0
0
Greece
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State/province [30]
0
0
Athens
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Country [31]
0
0
Greece
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State/province [31]
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0
Heraklion
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Country [32]
0
0
Hungary
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State/province [32]
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0
Budapest
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Country [33]
0
0
Hungary
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State/province [33]
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0
Debrecen
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Country [34]
0
0
Ireland
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State/province [34]
0
0
Dublin
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Country [35]
0
0
Italy
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State/province [35]
0
0
Lazio
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Country [36]
0
0
Italy
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State/province [36]
0
0
Bari
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Country [37]
0
0
Italy
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State/province [37]
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0
Milan
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Country [38]
0
0
Italy
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State/province [38]
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0
Pavia
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Country [39]
0
0
Italy
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State/province [39]
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0
Verona
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Country [40]
0
0
Netherlands
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State/province [40]
0
0
Amsterdam
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Country [41]
0
0
Netherlands
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State/province [41]
0
0
Arnhem
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Country [42]
0
0
Netherlands
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State/province [42]
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0
Leeuwarden
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Country [43]
0
0
Netherlands
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State/province [43]
0
0
Utrecht
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Country [44]
0
0
Spain
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State/province [44]
0
0
Barcelona
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Country [45]
0
0
Spain
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State/province [45]
0
0
Bilbao
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Country [46]
0
0
Spain
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State/province [46]
0
0
El Palmar
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Country [47]
0
0
Spain
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State/province [47]
0
0
Madrid
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Country [48]
0
0
Spain
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State/province [48]
0
0
Mostoles
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Country [49]
0
0
Spain
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State/province [49]
0
0
Santiago de Compostela
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Country [50]
0
0
Spain
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State/province [50]
0
0
Valencia
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Country [51]
0
0
Sweden
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State/province [51]
0
0
Uppsala Lan
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Country [52]
0
0
Sweden
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State/province [52]
0
0
Uppsala
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Country [53]
0
0
Sweden
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State/province [53]
0
0
Vasteras
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Country [54]
0
0
United Kingdom
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State/province [54]
0
0
London, City Of
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Country [55]
0
0
United Kingdom
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State/province [55]
0
0
Chelmsford
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Country [56]
0
0
United Kingdom
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State/province [56]
0
0
Edinburgh
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Country [57]
0
0
United Kingdom
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State/province [57]
0
0
Leeds
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Country [58]
0
0
United Kingdom
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State/province [58]
0
0
Liverpool
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Country [59]
0
0
United Kingdom
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State/province [59]
0
0
Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study was to investigate the association between residual
disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the
occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an
adalimumab dose tapering regimen controlled by adalimumab withdrawal.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02198651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
AbbVie Inc.
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Address
0
0
AbbVie
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02198651
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