Musculoskeletal and Connective Tissue Diseases, Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Adalimumab, Taper, Flare, Arthritis, Anti-rheumatic drugs, Remission, Magnetic Resonance Imaging, Ultrasound, Biomarker, Drug Level, Reduced dose
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.
Detailed description
This was a Phase 4, multicenter, randomized, double-blind, parallel-group study. The study included a Screening period of up to 28 days (unless extended with justification approved by study-designated physician), a 4-week Lead-In Period with open label (OL) 40 mg adalimumab administered subcutaneously (sc) every other week (eow), and a randomized 36-week double-blind period with 40 mg adalimumab sc every 3 weeks (q3wks; tapering arm) or placebo sc q3wks (withdrawal arm). Participants were randomized in a 5:1 ratio (tapering arm: withdrawal arm) after confirmation of meeting the disease activity score (DAS) criteria. Participants who experienced a protocol-defined flare at any time were to enter a rescue arm with OL 40 mg adalimumab administered sc eow for 16 weeks.
Interventions
BIOLOGICALAdalimumab
Pre-filled syringe, administered by subcutaneous injection
OTHERPlacebo
Pre-filled syringe, administered by subcutaneous injection in the Double-blind period
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Week 4 to Week 40 | 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. |
| Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm | From Week 4 to Week 40 | 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. |
| 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 | From Week 4 to Week 40 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Flare | From Week 4 to Week 40 | 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 \[ESR\]. |
| Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | From Flare Week 0 to Flare Week 16 | 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. |
| Median Time to Clinical Remission From the Occurrence of Flare | From Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| 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 | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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). |
| Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | From Week 4 to Week 40 or Final visit | 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. |
| Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | From Week 4 to Week 40 or Final visit | 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%. |
| Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | From Week 4 to Week 40 or Final Visit | 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. |
| Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Week 4 and Week 40 | 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. |
| Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15 | 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. |
| Mean Change From Double-blind Baseline in Swollen Joint Count 28 | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Swollen Joint Count 66 | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Tender Joint Count 28 | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Median Time to Flare | From Week 4 to Week 40 | 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. |
| Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Morning Stiffness Duration | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Morning Stiffness Severity | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16 | 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. |
| Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Mean Change From Double-blind Baseline in Tender Joint Count 68 | From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16 | 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. |
| Physicians' Assessment of Flare Severity | At the Flare Week 0 Visit | 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. |
| Participants' Assessment of Flare Severity | At the Flare Week 0 Visit | 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. |
Countries
Australia, Austria, Canada, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab 40 mg Eow 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period) | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Period | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Double-blind Period | Other, not specified | 0 | 4 | 1 | 0 | 0 |
| Double-blind Period | Withdrew consent | 0 | 4 | 0 | 0 | 0 |
| Lead-in Period | Adverse Event | 2 | 0 | 0 | 0 | 0 |
| Lead-in Period | Other, not specified | 22 | 0 | 0 | 0 | 0 |
| Lead-in Period | Withdrew consent | 13 | 0 | 0 | 0 | 0 |
| Open-label Rescue Period | Incorrectly entered Open-label Rescue | 0 | 0 | 0 | 1 | 0 |
| Open-label Rescue Period | Withdrew consent | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Adalimumab 40 mg Eow |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 10.3 |
| Disease duration | 12.9 years STANDARD_DEVIATION 9.99 |
| Duration of adalimumab therapy | 5.4 years STANDARD_DEVIATION 3.27 |
| Duration of remission | 2.2 years STANDARD_DEVIATION 1.99 |
| HAQ-DI Score | 0.4 units on a scale STANDARD_DEVIATION 0.51 |
| Mean C-Reactive Protein (CRP) | 2.4 mg/L STANDARD_DEVIATION 2.58 |
| Participants' Global Assessment of Disease Activity | 8.7 units on a scale STANDARD_DEVIATION 11.84 |
| Previous treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) No | 1 Participants |
| Previous treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) Yes | 145 Participants |
| Previous Tx with biological disease-modifying anti-rheumatic drugs (bDMARDs; excluding adalimumab) No | 108 Participants |
| Previous Tx with biological disease-modifying anti-rheumatic drugs (bDMARDs; excluding adalimumab) Yes | 38 Participants |
| Previous Tx with csDMARDS or bDMARDs (excluding adalimumab) No | 0 Participants |
| Previous Tx with csDMARDS or bDMARDs (excluding adalimumab) Yes | 146 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 139 Participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 37 Participants |
| Tobacco Use Current | 22 Participants |
| Tobacco Use Former | 46 Participants |
| Tobacco Use Never | 76 Participants |
| Tobacco Use Unknown | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 146 | 0 / 102 | 0 / 20 | 0 / 39 |
| other Total, other adverse events | 11 / 146 | 33 / 102 | 12 / 20 | 13 / 39 |
| serious Total, serious adverse events | 4 / 146 | 1 / 102 | 0 / 20 | 3 / 39 |
Outcome results
Primary
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
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
Population: Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Tapering | 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 | 0.979 odds ratio |
p-value: 0.688Wald Chi
Primary
Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm
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
Population: Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Tapering | Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm | 0.959 odds ratio |
p-value: 0.592Wald Chi
Primary
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
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
Population: Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Tapering | 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 | 0.993 odds ratio |
p-value: 0.943Wald Chi
Secondary
Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 16- Withdrawal Arm | 2.8 units on a scale | Standard Deviation 4.19 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 22- Withdrawal Arm | 2.2 units on a scale | Standard Deviation 1.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 28- Withdrawal arm | 6.3 units on a scale | Standard Deviation 8.4 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 28- Tapering arm | 3.7 units on a scale | Standard Deviation 6.19 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 34- Tapering Arm | 2.7 units on a scale | Standard Deviation 3.04 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 34- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 0.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 40- Tapering Arm | 7.4 units on a scale | Standard Deviation 10.04 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 40- Withdrawal Arm | 7.7 units on a scale | Standard Deviation 11.38 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 0- Tapering Arm | 12.3 units on a scale | Standard Deviation 9.56 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 0- Withdrawal Arm | 9.4 units on a scale | Standard Deviation 9.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 4- Tapering Arm | 5.0 units on a scale | Standard Deviation 6.55 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 4- Withdrawal Arm | 5.4 units on a scale | Standard Deviation 9.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 10- Tapering Arm | 3.5 units on a scale | Standard Deviation 4.55 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 10- Withdrawal Arm | 3.6 units on a scale | Standard Deviation 2.52 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Flare Week 16- Tapering Arm | 4.5 units on a scale | Standard Deviation 6.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 10- Tapering Arm | 4.4 units on a scale | Standard Deviation 7.68 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 10- Withdrawal Arm | 1.0 units on a scale | Standard Deviation 2.45 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 16- Tapering Arm | 7.0 units on a scale | Standard Deviation 9.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 16- Withdrawal Arm | 2.9 units on a scale | Standard Deviation 2.42 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 22- Tapering Arm | 3.2 units on a scale | Standard Deviation 4.98 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 28- Withdrawal arm | -0.1 units on a scale | Standard Deviation 0.8 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 28- Tapering arm | 0.5 units on a scale | Standard Deviation 1.37 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 10- Tapering Arm | 0.6 units on a scale | Standard Deviation 1.34 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 40- Tapering Arm | 0.1 units on a scale | Standard Deviation 1.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 10- Withdrawal Arm | 1.4 units on a scale | Standard Deviation 2.85 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 34- Tapering Arm | 0.2 units on a scale | Standard Deviation 1.08 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 16- Tapering Arm | 0.4 units on a scale | Standard Deviation 1.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 22- Tapering Arm | 0.3 units on a scale | Standard Deviation 1.38 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 16- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 0.88 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 34- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 0.92 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 22- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.73 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score | Double Blind Week 40- Withdrawal Arm | -0.3 units on a scale | Standard Deviation 0.48 |
Secondary
Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 16- Tapering Arm | 1.2 units on a scale | Standard Deviation 1.34 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 40- Tapering Arm | 1.5 units on a scale | Standard Deviation 1.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 40- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 2.18 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 22- Withdrawal Arm | 0.5 units on a scale | Standard Deviation 0.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 0- Tapering Arm | 2.3 units on a scale | Standard Deviation 1.15 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 0- Withdrawal Arm | 1.9 units on a scale | Standard Deviation 0.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 4- Tapering Arm | 1.3 units on a scale | Standard Deviation 1.05 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 4- Withdrawal Arm | 1.2 units on a scale | Standard Deviation 1.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 10- Tapering Arm | 0.9 units on a scale | Standard Deviation 0.81 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 10- Withdrawal Arm | 0.7 units on a scale | Standard Deviation 0.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 16- Tapering Arm | 1.2 units on a scale | Standard Deviation 1.04 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Flare Week 16- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 0.8 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 10- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.47 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 28- Tapering arm | 0.8 units on a scale | Standard Deviation 1.16 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 16- Withdrawal Arm | 0.9 units on a scale | Standard Deviation 0.58 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 28- Withdrawal arm | 1.0 units on a scale | Standard Deviation 1.54 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 10- Tapering Arm | 0.7 units on a scale | Standard Deviation 1.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 34- Tapering Arm | 0.7 units on a scale | Standard Deviation 0.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 22- Tapering Arm | 0.7 units on a scale | Standard Deviation 1.18 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 34- Withdrawal Arm | -0.7 units on a scale | Standard Deviation 0.11 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 28- Withdrawal arm | 0.2 units on a scale | Standard Deviation 0.25 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 10- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.46 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 10- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.55 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 16- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.39 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 16- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 0.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 22- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.53 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 22- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.24 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 28- Tapering arm | 0.1 units on a scale | Standard Deviation 0.5 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 40- Tapering Arm | 0.0 units on a scale | Standard Deviation 0.52 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 34- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.54 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 34- Withdrawal Arm | -0.0 units on a scale | Standard Deviation 0.46 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28) | Double Blind Week 40- Withdrawal Arm | 0.2 units on a scale | Standard Deviation 0.38 |
Secondary
Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 16- Withdrawal Arm | -1.7 units on a scale | Standard Deviation 1.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 4- Tapering Arm | -3.8 units on a scale | Standard Deviation 9.19 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 4- Withdrawal Arm | -4.7 units on a scale | Standard Deviation 5.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 10- Tapering Arm | -3.9 units on a scale | Standard Deviation 8.44 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 10- Withdrawal Arm | -2.4 units on a scale | Standard Deviation 4.47 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 16- Tapering Arm | -4.5 units on a scale | Standard Deviation 9.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 16- Tapering Arm | -6.0 units on a scale | Standard Deviation 9.8 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 16- Withdrawal Arm | -2.3 units on a scale | Standard Deviation 3.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 28- Tapering arm | -3.5 units on a scale | Standard Deviation 7.58 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 28- Withdrawal Arm | -4.3 units on a scale | Standard Deviation 7.23 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 40- Tapering Arm | -6.4 units on a scale | Standard Deviation 8.44 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 40- Withdrawal Arm | -2.5 units on a scale | Standard Deviation 6.36 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 0- Tapering Arm | -7.4 units on a scale | Standard Deviation 11.17 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Flare Week 0- Withdrawal Arm | -3.6 units on a scale | Standard Deviation 4.75 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 16- Tapering Arm | -1.5 units on a scale | Standard Deviation 5.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 28- Withdrawal Arm | -2.2 units on a scale | Standard Deviation 4.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 16- Withdrawal Arm | -1.9 units on a scale | Standard Deviation 3.27 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 40- Withdrawal Arm | -1.5 units on a scale | Standard Deviation 4.78 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 28- Tapering arm | -1.6 units on a scale | Standard Deviation 5.6 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Double Blind Week 40- Tapering Arm | -0.4 units on a scale | Standard Deviation 4 |
Secondary
Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 10- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.3 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 22- Withdrawal Arm | 0.4 units on a scale | Standard Deviation 0.79 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 28- Tapering Arm | 0.2 units on a scale | Standard Deviation 0.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 28- Withdrawal Arm | 0.7 units on a scale | Standard Deviation 0.69 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 34- Withdrawal Arm | 0.2 units on a scale | Standard Deviation 0.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 40- Tapering Arm | 0.4 units on a scale | Standard Deviation 0.4 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 40- Withdrawal Arm | 1.9 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 0- Withdrawal Arm | 0.3 units on a scale | Standard Deviation 0.29 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 4- Withdrawal Arm | 0.2 units on a scale | Standard Deviation 0.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 10- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 10- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 16- Tapering Arm | 0.2 units on a scale | Standard Deviation 0.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 16- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 16- Withdrawal Arm | 0.3 units on a scale | Standard Deviation 0.54 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 0- Tapering Arm | 0.4 units on a scale | Standard Deviation 0.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Flare Week 4- Tapering Arm | 0.2 units on a scale | Standard Deviation 0.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 34- Tapering Arm | 0.3 units on a scale | Standard Deviation 0.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 10- Withdrawal Arm | 0.3 units on a scale | Standard Deviation 0.61 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 16- Tapering Arm | 0.2 units on a scale | Standard Deviation 0.4 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 22- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.37 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 10- Tapering Arm | 0.0 units on a scale | Standard Deviation 0.18 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 10- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 0.17 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 16- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.28 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 40- Tapering Arm | -0.1 units on a scale | Standard Deviation 0.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 22- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.39 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 34- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.17 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 28- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.27 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 40- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 0.16 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 28- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 0.15 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 16- Withdrawal Arm | -0.0 units on a scale | Standard Deviation 0.12 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 34- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time | Double Blind Week 22- Tapering Arm | -0.0 units on a scale | Standard Deviation 0.26 |
Secondary
Mean Change From Double-blind Baseline in Morning Stiffness Duration
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 16- Withdrawal Arm | 9.6 minutes | Standard Deviation 20.65 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 34- Tapering Arm | 0.6 minutes | Standard Deviation 10.97 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 34- Withdrawal Arm | 0.0 minutes | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 40- Tapering Arm | 2.0 minutes | Standard Deviation 12.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 40- Withdrawal Arm | 0.0 minutes | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 0- Tapering Arm | 13.5 minutes | Standard Deviation 25.21 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 0- Withdrawal Arm | 18.5 minutes | Standard Deviation 26.25 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 4- Tapering Arm | 25.0 minutes | Standard Deviation 110.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 4- Withdrawal Arm | 19.9 minutes | Standard Deviation 26.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 10- Tapering Arm | 8.1 minutes | Standard Deviation 30.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 10- Withdrawal Arm | 7.9 minutes | Standard Deviation 9.72 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Flare Week 16- Tapering Arm | 17.3 minutes | Standard Deviation 36.46 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 22- Tapering Arm | -1.6 minutes | Standard Deviation 8.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 22- Withdrawal arm | 1.0 minutes | Standard Deviation 2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 28- Tapering arm | 2.6 minutes | Standard Deviation 13.09 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 10- Tapering Arm | 3.5 minutes | Standard Deviation 17.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 10- Withdrawal Arm | 1.1 minutes | Standard Deviation 3.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 16- Tapering Arm | 6.6 minutes | Standard Deviation 24.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 16- Withdrawal Arm | 9.2 minutes | Standard Deviation 19.78 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 28- Withdrawal Arm | 17.3 minutes | Standard Deviation 28.81 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 22- Tapering Arm | 1.5 minutes | Standard Deviation 9.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 22- Withdrawal arm | 0.5 minutes | Standard Deviation 3.7 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 34- Withdrawal Arm | -1.1 minutes | Standard Deviation 6.64 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 28- Tapering arm | 2.4 minutes | Standard Deviation 10.53 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 28- Withdrawal Arm | 0.0 minutes | Standard Deviation 3.71 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 10- Tapering Arm | 1.8 minutes | Standard Deviation 7.19 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 40- Withdrawal Arm | -0.2 minutes | Standard Deviation 5.78 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 10- Withdrawal Arm | 1.5 minutes | Standard Deviation 5.97 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 34- Tapering Arm | 1.4 minutes | Standard Deviation 8.86 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 16- Tapering Arm | 2.3 minutes | Standard Deviation 12.54 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 40- Tapering Arm | 0.4 minutes | Standard Deviation 9.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Duration | Double Blind Week 16- Withdrawal Arm | -0.6 minutes | Standard Deviation 5.05 |
Secondary
Mean Change From Double-blind Baseline in Morning Stiffness Severity
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 16- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 1.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 34- Tapering Arm | 1.3 units on a scale | Standard Deviation 1.71 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 34- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 1.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 40- Tapering Arm | 1.8 units on a scale | Standard Deviation 2.52 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 40- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 1.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 0- Tapering Arm | 1.6 units on a scale | Standard Deviation 2.11 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 0- Withdrawal Arm | 0.9 units on a scale | Standard Deviation 1.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 4- Tapering Arm | 0.8 units on a scale | Standard Deviation 2.21 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 4- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 1.72 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 10- Tapering Arm | 0.6 units on a scale | Standard Deviation 1.4 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 10- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 1.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Flare Week 16- Tapering Arm | 0.6 units on a scale | Standard Deviation 1.45 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 10- Tapering Arm | 0.6 units on a scale | Standard Deviation 1.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 10- Withdrawal Arm | 0.4 units on a scale | Standard Deviation 1.81 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 16- Tapering Arm | 0.8 units on a scale | Standard Deviation 1.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 16- Withdrawal Arm | 0.7 units on a scale | Standard Deviation 2.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 22- Tapering Arm | 0.9 units on a scale | Standard Deviation 1.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 22- Withdrawal arm | 0.8 units on a scale | Standard Deviation 0.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 28- Tapering arm | 0.9 units on a scale | Standard Deviation 1.69 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 28- Withdrawal Arm | 1.3 units on a scale | Standard Deviation 2.75 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 10- Tapering Arm | 0.4 units on a scale | Standard Deviation 1.01 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 28- Tapering arm | 0.2 units on a scale | Standard Deviation 1.1 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 10- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 1.29 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 34- Withdrawal Arm | -0.2 units on a scale | Standard Deviation 1.08 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 16- Tapering Arm | 0.3 units on a scale | Standard Deviation 1.11 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 28- Withdrawal Arm | -0.2 units on a scale | Standard Deviation 0.87 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 16- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 1.04 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 40- Withdrawal Arm | -0.4 units on a scale | Standard Deviation 1.03 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 22- Tapering Arm | 0.2 units on a scale | Standard Deviation 0.85 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 34- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.85 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 22- Withdrawal arm | 0.4 units on a scale | Standard Deviation 1.75 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Morning Stiffness Severity | Double Blind Week 40- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.94 |
Secondary
Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 4- Withdrawal Arm | 1.6 units on a scale | Standard Deviation 10.05 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 10- Tapering Arm | 2.1 units on a scale | Standard Deviation 15.37 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 28- Withdrawal Arm | 4.5 units on a scale | Standard Deviation 19.82 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 34- Tapering Arm | 5.6 units on a scale | Standard Deviation 22.99 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 34- Withdrawal Arm | -0.5 units on a scale | Standard Deviation 30.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 40- Tapering Arm | 17.7 units on a scale | Standard Deviation 34.04 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 40- Withdrawal Arm | -8.0 units on a scale | Standard Deviation 15.56 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 0- Tapering Arm | 18.9 units on a scale | Standard Deviation 26.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 0- Withdrawal Arm | 4.0 units on a scale | Standard Deviation 14.61 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 4- Tapering Arm | 4.9 units on a scale | Standard Deviation 24.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 10- Tapering Arm | 0.2 units on a scale | Standard Deviation 21.26 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 10- Withdrawal Arm | 3.9 units on a scale | Standard Deviation 12.98 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 16- Tapering Arm | 2.3 units on a scale | Standard Deviation 20.17 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Flare Week 16- Withdrawal Arm | -7.3 units on a scale | Standard Deviation 14.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 10- Withdrawal Arm | -3.2 units on a scale | Standard Deviation 29.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 16- Tapering Arm | 10.2 units on a scale | Standard Deviation 19.12 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 16- Withdrawal Arm | 7.1 units on a scale | Standard Deviation 22.42 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 22- Tapering Arm | 8.2 units on a scale | Standard Deviation 19.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 22- Withdrawal arm | 8.3 units on a scale | Standard Deviation 31.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 28- Tapering arm | 1.8 units on a scale | Standard Deviation 27.81 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 10- Tapering Arm | 0.0 units on a scale | Standard Deviation 8.99 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 28- Tapering arm | 2.1 units on a scale | Standard Deviation 12.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 10- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 1.54 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 34- Withdrawal Arm | -0.4 units on a scale | Standard Deviation 2.77 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 16- Tapering Arm | 1.7 units on a scale | Standard Deviation 15.96 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 28- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 7.63 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 16- Withdrawal Arm | 1.1 units on a scale | Standard Deviation 3.02 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 40- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 4.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 22- Tapering Arm | -0.3 units on a scale | Standard Deviation 10.91 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 34- Tapering Arm | -0.4 units on a scale | Standard Deviation 11.48 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 22- Withdrawal arm | 3.5 units on a scale | Standard Deviation 8.7 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance | Double Blind Week 40- Tapering Arm | -0.2 units on a scale | Standard Deviation 12.4 |
Secondary
Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 16- Withdrawal Arm | 6.9 units on a scale | Standard Deviation 9.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 34- Tapering Arm | 11.5 units on a scale | Standard Deviation 13.7 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 34- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 1.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 40- Tapering Arm | 22.9 units on a scale | Standard Deviation 35.32 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 40- Withdrawal Arm | 2.0 units on a scale | Standard Deviation 9.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 0- Tapering Arm | 29.5 units on a scale | Standard Deviation 29.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 0- Withdrawal Arm | 21.6 units on a scale | Standard Deviation 27.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 4- Tapering Arm | 13.7 units on a scale | Standard Deviation 22.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 4- Withdrawal Arm | 11.7 units on a scale | Standard Deviation 21.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 10- Tapering Arm | 11.7 units on a scale | Standard Deviation 16.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 10- Withdrawal Arm | 14.1 units on a scale | Standard Deviation 10.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Flare Week 16- Tapering Arm | 9.4 units on a scale | Standard Deviation 13.47 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 10- Tapering Arm | 11.6 units on a scale | Standard Deviation 19 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 10- Withdrawal Arm | 8.0 units on a scale | Standard Deviation 21.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 16- Tapering Arm | 20.5 units on a scale | Standard Deviation 26.97 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 16- Withdrawal Arm | 10.7 units on a scale | Standard Deviation 19.97 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 22- Tapering Arm | 10.7 units on a scale | Standard Deviation 17.74 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 22- Withdrawal arm | 5.8 units on a scale | Standard Deviation 8.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 28- Tapering arm | 9.4 units on a scale | Standard Deviation 21.03 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 28- Withdrawal Arm | 15.0 units on a scale | Standard Deviation 25.76 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 10- Tapering Arm | 2.6 units on a scale | Standard Deviation 8.49 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 28- Tapering arm | 2.7 units on a scale | Standard Deviation 10.03 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 10- Withdrawal Arm | 9.6 units on a scale | Standard Deviation 20.27 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 34- Withdrawal Arm | 0.7 units on a scale | Standard Deviation 7.25 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 16- Tapering Arm | 2.4 units on a scale | Standard Deviation 9.27 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 28- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 7.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 16- Withdrawal Arm | -0.3 units on a scale | Standard Deviation 5.76 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 40- Withdrawal Arm | -1.7 units on a scale | Standard Deviation 4.45 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 22- Tapering Arm | 1.7 units on a scale | Standard Deviation 9.14 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 34- Tapering Arm | 1.2 units on a scale | Standard Deviation 7.23 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 22- Withdrawal arm | 0.2 units on a scale | Standard Deviation 8.87 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity | Double Blind Week 40- Tapering Arm | 0.0 units on a scale | Standard Deviation 7.6 |
Secondary
Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 16- Withdrawal Arm | 4.3 units on a scale | Standard Deviation 6.32 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 34- Tapering Arm | 11.6 units on a scale | Standard Deviation 14.61 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 34- Withdrawal Arm | -3.5 units on a scale | Standard Deviation 2.12 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 40- Tapering Arm | 24.0 units on a scale | Standard Deviation 32.67 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 40- Withdrawal Arm | -0.5 units on a scale | Standard Deviation 20.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 0- Tapering Arm | 24.4 units on a scale | Standard Deviation 31.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 0- Withdrawal Arm | 17.0 units on a scale | Standard Deviation 19.38 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 4- Tapering Arm | 9.0 units on a scale | Standard Deviation 21.68 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 4- Withdrawal Arm | 11.1 units on a scale | Standard Deviation 17.46 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 10- Tapering Arm | 7.5 units on a scale | Standard Deviation 14.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 10- Withdrawal Arm | 8.3 units on a scale | Standard Deviation 9.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Flare Week 16- Tapering Arm | 8.0 units on a scale | Standard Deviation 14.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 10- Tapering Arm | 8.0 units on a scale | Standard Deviation 17.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 10- Withdrawal Arm | 6.4 units on a scale | Standard Deviation 19.05 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 16- Tapering Arm | 17.8 units on a scale | Standard Deviation 27.16 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 16- Withdrawal Arm | 10.7 units on a scale | Standard Deviation 18.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 22- Tapering Arm | 10.4 units on a scale | Standard Deviation 19.55 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 22- Withdrawal arm | 4.0 units on a scale | Standard Deviation 4.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 28- Tapering arm | 8.3 units on a scale | Standard Deviation 17.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 28- Withdrawal Arm | 14.0 units on a scale | Standard Deviation 24.59 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 10- Tapering Arm | 3.5 units on a scale | Standard Deviation 14.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 28- Tapering arm | 1.6 units on a scale | Standard Deviation 9.83 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 10- Withdrawal Arm | 9.3 units on a scale | Standard Deviation 21.04 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 34- Withdrawal Arm | 2.1 units on a scale | Standard Deviation 8.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 16- Tapering Arm | 3.0 units on a scale | Standard Deviation 12.48 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 28- Withdrawal Arm | -1.4 units on a scale | Standard Deviation 10.93 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 16- Withdrawal Arm | -0.6 units on a scale | Standard Deviation 9.65 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 40- Withdrawal Arm | -0.9 units on a scale | Standard Deviation 5.07 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 22- Tapering Arm | 0.3 units on a scale | Standard Deviation 7.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 34- Tapering Arm | -0.3 units on a scale | Standard Deviation 7.61 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 22- Withdrawal arm | -1.1 units on a scale | Standard Deviation 11.2 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain | Double Blind Week 40- Tapering Arm | -0.5 units on a scale | Standard Deviation 10 |
Secondary
Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 10- Tapering Arm | 10.2 units on a scale | Standard Deviation 19.54 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 34- Tapering Arm | 5.5 units on a scale | Standard Deviation 12.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 34- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 40- Tapering Arm | 16.2 units on a scale | Standard Deviation 26.91 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 40- Withdrawal Arm | 19.5 units on a scale | Standard Deviation 26.16 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 0- Tapering Arm | 26.5 units on a scale | Standard Deviation 23.28 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 0- Withdrawal Arm | 17.4 units on a scale | Standard Deviation 15.37 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 4- Tapering Arm | 12.2 units on a scale | Standard Deviation 17.06 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 4- Withdrawal Arm | 9.3 units on a scale | Standard Deviation 20.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 10- Tapering Arm | 10.2 units on a scale | Standard Deviation 13.82 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 10- Withdrawal Arm | 12.9 units on a scale | Standard Deviation 11.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 16- Tapering Arm | 8.6 units on a scale | Standard Deviation 12.48 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Flare Week 16- Withdrawal Arm | 7.6 units on a scale | Standard Deviation 20 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 10- Withdrawal Arm | 1.6 units on a scale | Standard Deviation 4.67 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 16- Tapering Arm | 13.2 units on a scale | Standard Deviation 21.48 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 16- Withdrawal Arm | 5.0 units on a scale | Standard Deviation 3.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 22- Tapering Arm | 6.9 units on a scale | Standard Deviation 14.83 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 22- Withdrawal arm | 3.8 units on a scale | Standard Deviation 2.87 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 28- Tapering arm | 7.3 units on a scale | Standard Deviation 16.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 28- Withdrawal Arm | 10.0 units on a scale | Standard Deviation 10.89 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 10- Tapering Arm | 1.3 units on a scale | Standard Deviation 4.27 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 40- Withdrawal Arm | -0.6 units on a scale | Standard Deviation 2.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 10- Withdrawal Arm | 0.5 units on a scale | Standard Deviation 4.74 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 28- Tapering arm | 1.7 units on a scale | Standard Deviation 5.51 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 16- Tapering Arm | 0.9 units on a scale | Standard Deviation 5.07 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 40- Tapering Arm | 1.0 units on a scale | Standard Deviation 5.32 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 16- Withdrawal Arm | -0.5 units on a scale | Standard Deviation 2.98 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 28- Withdrawal Arm | -0.9 units on a scale | Standard Deviation 2.74 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 22- Tapering Arm | 0.9 units on a scale | Standard Deviation 5.05 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 34- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 4.13 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 22- Withdrawal arm | 0.4 units on a scale | Standard Deviation 3.26 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity | Double Blind Week 34- Tapering Arm | 0.8 units on a scale | Standard Deviation 3.6 |
Secondary
Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 16- Withdrawal Arm | 2.1 units on a scale | Standard Deviation 3.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 10- Tapering Arm | 1.9 units on a scale | Standard Deviation 3.92 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 28- Withdrawal Arm | 3.7 units on a scale | Standard Deviation 4.45 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 34- Tapering Arm | 2.2 units on a scale | Standard Deviation 3.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 34- Withdrawal Arm | 1.9 units on a scale | Standard Deviation 2.62 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 40- Tapering Arm | 4.7 units on a scale | Standard Deviation 6.22 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 40- Withdrawal Arm | 0.4 units on a scale | Standard Deviation 0.92 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 0- Tapering Arm | 6.1 units on a scale | Standard Deviation 6.64 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 0- Withdrawal Arm | 3.9 units on a scale | Standard Deviation 5.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 4- Tapering Arm | 3.1 units on a scale | Standard Deviation 5.38 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 4- Withdrawal Arm | 3.2 units on a scale | Standard Deviation 4.15 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 10- Tapering Arm | 2.8 units on a scale | Standard Deviation 3.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 10- Withdrawal Arm | 2.3 units on a scale | Standard Deviation 2.61 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Flare Week 16- Tapering Arm | 2.9 units on a scale | Standard Deviation 4.22 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 10- Withdrawal Arm | 1.4 units on a scale | Standard Deviation 3.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 16- Tapering Arm | 4.7 units on a scale | Standard Deviation 5.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 16- Withdrawal Arm | 2.5 units on a scale | Standard Deviation 4.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 22- Tapering Arm | 2.6 units on a scale | Standard Deviation 4.83 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 22- Withdrawal arm | 3.6 units on a scale | Standard Deviation 4.18 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 28- Tapering arm | 2.2 units on a scale | Standard Deviation 4.2 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 10- Tapering Arm | 0.7 units on a scale | Standard Deviation 3.2 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 28- Tapering arm | 0.6 units on a scale | Standard Deviation 2.47 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 10- Withdrawal Arm | 1.5 units on a scale | Standard Deviation 4.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 40- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 1.62 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 16- Tapering Arm | 0.8 units on a scale | Standard Deviation 2.8 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 40- Tapering Arm | 0.0 units on a scale | Standard Deviation 2.39 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 16- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 1.37 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 34- Tapering Arm | -0.0 units on a scale | Standard Deviation 1.93 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 22- Tapering Arm | 0.3 units on a scale | Standard Deviation 2.83 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 28- Withdrawal Arm | -0.3 units on a scale | Standard Deviation 1.61 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 22- Withdrawal arm | 0.6 units on a scale | Standard Deviation 3.31 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits | Double Blind Week 34- Withdrawal Arm | 1.6 units on a scale | Standard Deviation 2.33 |
Secondary
Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 16- Withdrawal Arm | -0.8 mg/L | Standard Deviation 2.74 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 34- Tapering Arm | 3.2 mg/L | Standard Deviation 10.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 34- Withdrawal Arm | 1.8 mg/L | Standard Deviation 1.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 40- Tapering Arm | 1.0 mg/L | Standard Deviation 5.69 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 40- Withdrawal Arm | 8.3 mg/L | Standard Deviation 11.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 0- Tapering Arm | -7.4 mg/L | Standard Deviation 54.12 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 0- Withdrawal Arm | 5.4 mg/L | Standard Deviation 12.67 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 4- Tapering Arm | -8.5 mg/L | Standard Deviation 55.47 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 4- Withdrawal Arm | -1.3 mg/L | Standard Deviation 4.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 10- Tapering Arm | -9.5 mg/L | Standard Deviation 55.61 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 10- Withdrawal Arm | -0.6 mg/L | Standard Deviation 0.97 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Flare Week 16- Tapering Arm | -9.1 mg/L | Standard Deviation 53.7 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 10- Tapering Arm | -7.9 mg/L | Standard Deviation 48.87 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 10- Withdrawal Arm | -0.2 mg/L | Standard Deviation 3.55 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 16- Tapering Arm | -7.4 mg/L | Standard Deviation 49.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 16- Withdrawal Arm | 6.6 mg/L | Standard Deviation 12.26 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 22- Tapering Arm | 3.6 mg/L | Standard Deviation 9.69 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 22- Withdrawal arm | 0.6 mg/L | Standard Deviation 0.37 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 28- Tapering arm | 0.5 mg/L | Standard Deviation 3.85 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 28- Withdrawal Arm | 1.1 mg/L | Standard Deviation 1.34 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 10- Tapering Arm | 1.7 mg/L | Standard Deviation 12.92 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 28- Tapering arm | -0.4 mg/L | Standard Deviation 4.65 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 10- Withdrawal Arm | -0.6 mg/L | Standard Deviation 2.53 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 34- Withdrawal Arm | 0.3 mg/L | Standard Deviation 5.98 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 16- Tapering Arm | -0.4 mg/L | Standard Deviation 4.26 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 28- Withdrawal Arm | 2.5 mg/L | Standard Deviation 11.6 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 16- Withdrawal Arm | -0.1 mg/L | Standard Deviation 3.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 40- Withdrawal Arm | -0.1 mg/L | Standard Deviation 3.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 22- Tapering Arm | -0.0 mg/L | Standard Deviation 5.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 34- Tapering Arm | -0.4 mg/L | Standard Deviation 4.41 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 22- Withdrawal arm | -0.9 mg/L | Standard Deviation 3.38 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP) | Double Blind Week 40- Tapering Arm | -0.3 mg/L | Standard Deviation 4.18 |
Secondary
Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 16- Withdrawal Arm | 7.0 mm/hour | Standard Deviation 14.4 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 34- Tapering Arm | 4.8 mm/hour | Standard Deviation 7.28 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 34- Withdrawal Arm | -5.0 mm/hour | Standard Deviation 1.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 40- Tapering Arm | 10.2 mm/hour | Standard Deviation 13.22 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 40- Withdrawal Arm | -2.0 mm/hour | Standard Deviation 5.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 0- Tapering Arm | 10.4 mm/hour | Standard Deviation 12.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 0- Withdrawal Arm | 13.0 mm/hour | Standard Deviation 11.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 4- Tapering Arm | 7.2 mm/hour | Standard Deviation 9.82 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 4- Withdrawal Arm | 8.5 mm/hour | Standard Deviation 9.52 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 10- Tapering Arm | 5.8 mm/hour | Standard Deviation 10.16 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 10- Withdrawal Arm | 4.4 mm/hour | Standard Deviation 6.91 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Flare Week 16- Tapering Arm | 8.0 mm/hour | Standard Deviation 10.95 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 10- Tapering Arm | 4.1 mm/hour | Standard Deviation 11.25 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 10- Withdrawal Arm | 0.9 mm/hour | Standard Deviation 9.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 16- Tapering Arm | 4.6 mm/hour | Standard Deviation 10.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 16- Withdrawal Arm | 5.2 mm/hour | Standard Deviation 15.23 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 22- Tapering Arm | 3.5 mm/hour | Standard Deviation 10.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 22- Withdrawal arm | 2.8 mm/hour | Standard Deviation 9.22 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 28- Tapering arm | 3.4 mm/hour | Standard Deviation 8.18 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 28- Withdrawal Arm | 6.0 mm/hour | Standard Deviation 10.1 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 10- Tapering Arm | 0.7 mm/hour | Standard Deviation 5.22 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 28- Tapering arm | 0.4 mm/hour | Standard Deviation 6.93 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 10- Withdrawal Arm | -1.5 mm/hour | Standard Deviation 5.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 34- Withdrawal Arm | -0.5 mm/hour | Standard Deviation 5.94 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 16- Tapering Arm | 0.5 mm/hour | Standard Deviation 5.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 28- Withdrawal Arm | 1.0 mm/hour | Standard Deviation 5.04 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 16- Withdrawal Arm | -0.3 mm/hour | Standard Deviation 5.31 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 40- Withdrawal Arm | 4.7 mm/hour | Standard Deviation 8.89 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 22- Tapering Arm | -0.5 mm/hour | Standard Deviation 7.38 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 34- Tapering Arm | 0.3 mm/hour | Standard Deviation 7.57 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 22- Withdrawal arm | -0.3 mm/hour | Standard Deviation 4.22 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR) | Double Blind Week 40- Tapering Arm | 1.4 mm/hour | Standard Deviation 7.19 |
Secondary
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 40- Withdrawal Arm | -8.5 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 4- Tapering Arm | -2.0 units on a scale | Standard Deviation 5.95 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 28- Tapering arm | -5.5 units on a scale | Standard Deviation 11.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 10- Tapering Arm | -1.1 units on a scale | Standard Deviation 10.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 10- Withdrawal Arm | -0.4 units on a scale | Standard Deviation 3.06 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 16- Tapering Arm | -4.0 units on a scale | Standard Deviation 11.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 16- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 2.55 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 28- Withdrawal Arm | -5.2 units on a scale | Standard Deviation 5.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 40- Tapering Arm | -3.5 units on a scale | Standard Deviation 11.14 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 0- Tapering Arm | -4.1 units on a scale | Standard Deviation 11.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 0- Withdrawal Arm | 0.4 units on a scale | Standard Deviation 4.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Flare Week 4- Withdrawal Arm | -0.5 units on a scale | Standard Deviation 2.51 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 28- Tapering arm | -0.8 units on a scale | Standard Deviation 6.02 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 40- Tapering Arm | -0.8 units on a scale | Standard Deviation 5.89 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 28- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 7.2 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score | Double Blind Week 40- Withdrawal Arm | -0.4 units on a scale | Standard Deviation 6.71 |
Secondary
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 16- Withdrawal Arm | -2.5 units on a scale | Standard Deviation 2.8 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 10- Tapering Arm | -4.0 units on a scale | Standard Deviation 7.22 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 10- Withdrawal Arm | -4.0 units on a scale | Standard Deviation 4.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 16- Tapering Arm | -3.8 units on a scale | Standard Deviation 7.38 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 28- Tapering arm | -2.9 units on a scale | Standard Deviation 7.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 28- Withdrawal Arm | -1.9 units on a scale | Standard Deviation 7.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 40- Tapering Arm | -5.5 units on a scale | Standard Deviation 6.42 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 40- Withdrawal Arm | -1.6 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 0- Tapering Arm | -10.8 units on a scale | Standard Deviation 10.85 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 0- Withdrawal Arm | -2.4 units on a scale | Standard Deviation 10.81 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 4- Tapering Arm | -5.2 units on a scale | Standard Deviation 8.37 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Flare Week 4- Withdrawal Arm | -8.0 units on a scale | Standard Deviation 7.35 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 28- Tapering arm | -1.1 units on a scale | Standard Deviation 4.18 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 40- Tapering Arm | -0.4 units on a scale | Standard Deviation 5.53 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 28- Withdrawal Arm | -2.4 units on a scale | Standard Deviation 3.97 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score | Double Blind Week 40- Withdrawal Arm | -2.1 units on a scale | Standard Deviation 5.22 |
Secondary
Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 10- Withdrawal Arm | 0.9 units on a scale | Standard Deviation 2.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 34- Tapering Arm | 3.0 units on a scale | Standard Deviation 3.29 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 34- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 40- Tapering Arm | 7.5 units on a scale | Standard Deviation 10.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 40- Withdrawal Arm | 8.5 units on a scale | Standard Deviation 10.23 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 0- Tapering Arm | 11.6 units on a scale | Standard Deviation 11.17 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 0- Withdrawal Arm | 9.9 units on a scale | Standard Deviation 8.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 4- Tapering Arm | 4.1 units on a scale | Standard Deviation 8.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 4- Withdrawal Arm | 5.2 units on a scale | Standard Deviation 9.64 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 10- Tapering Arm | 2.5 units on a scale | Standard Deviation 7.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 10- Withdrawal Arm | 3.5 units on a scale | Standard Deviation 2.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 16- Tapering Arm | 3.6 units on a scale | Standard Deviation 6.63 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Flare Week 16- Withdrawal Arm | 2.7 units on a scale | Standard Deviation 4.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 16- Tapering Arm | 6.3 units on a scale | Standard Deviation 10.25 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 10- Tapering Arm | 3.7 units on a scale | Standard Deviation 8.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 16- Withdrawal Arm | 3.6 units on a scale | Standard Deviation 2.8 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 22- Tapering Arm | 3.6 units on a scale | Standard Deviation 5.18 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 22- Withdrawal Arm | 2.3 units on a scale | Standard Deviation 1.95 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 28- Tapering arm | 3.8 units on a scale | Standard Deviation 6.34 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 28- Withdrawal arm | 6.4 units on a scale | Standard Deviation 8.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 10- Withdrawal Arm | 1.3 units on a scale | Standard Deviation 2.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 34- Tapering Arm | 0.2 units on a scale | Standard Deviation 1.17 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 40- Withdrawal Arm | -0.3 units on a scale | Standard Deviation 0.62 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 28- Tapering arm | 0.4 units on a scale | Standard Deviation 1.37 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 10- Tapering Arm | 0.8 units on a scale | Standard Deviation 1.85 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 16- Tapering Arm | 0.4 units on a scale | Standard Deviation 1.35 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 40- Tapering Arm | 0.1 units on a scale | Standard Deviation 1.37 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 16- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 0.9 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 28- Withdrawal arm | 0.1 units on a scale | Standard Deviation 1.61 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 22- Tapering Arm | 0.3 units on a scale | Standard Deviation 1.47 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 34- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 1.07 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score | Double Blind Week 22- Withdrawal Arm | -0.0 units on a scale | Standard Deviation 0.88 |
Secondary
Mean Change From Double-blind Baseline in Swollen Joint Count 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 16- Withdrawal Arm | 0.3 swollen joint counts | Standard Deviation 0.46 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 34- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 34- Withdrawal Arm | 0.0 swollen joint counts | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 4- Withdrawal Arm | 0.6 swollen joint counts | Standard Deviation 1.06 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 40- Tapering Arm | 1.5 swollen joint counts | Standard Deviation 3.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 40- Withdrawal Arm | 2.0 swollen joint counts | Standard Deviation 2.83 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 0- Tapering Arm | 2.3 swollen joint counts | Standard Deviation 2.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 0- Withdrawal Arm | 1.9 swollen joint counts | Standard Deviation 2.1 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 4- Tapering Arm | 1.2 swollen joint counts | Standard Deviation 1.98 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 10- Tapering Arm | 0.4 swollen joint counts | Standard Deviation 0.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 10- Withdrawal Arm | 0.1 swollen joint counts | Standard Deviation 0.35 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Flare Week 16- Tapering Arm | 0.9 swollen joint counts | Standard Deviation 1.81 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 10- Tapering Arm | 0.9 swollen joint counts | Standard Deviation 2.09 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 10- Withdrawal Arm | 0.1 swollen joint counts | Standard Deviation 0.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 16- Tapering Arm | 1.2 swollen joint counts | Standard Deviation 2.15 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 16- Withdrawal Arm | 0.3 swollen joint counts | Standard Deviation 0.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 22- Tapering Arm | 0.6 swollen joint counts | Standard Deviation 1.64 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 22- Withdrawal arm | 0.5 swollen joint counts | Standard Deviation 0.58 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 28- Tapering arm | 0.5 swollen joint counts | Standard Deviation 0.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 28- Withdrawal Arm | 2.0 swollen joint counts | Standard Deviation 2.45 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 10- Tapering Arm | 0.1 swollen joint counts | Standard Deviation 0.58 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 28- Tapering arm | 0.0 swollen joint counts | Standard Deviation 0.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 10- Withdrawal Arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 34- Withdrawal Arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 16- Tapering Arm | -0.0 swollen joint counts | Standard Deviation 0.34 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 28- Withdrawal Arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 16- Withdrawal Arm | 0.0 swollen joint counts | Standard Deviation 0.45 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 40- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 22- Tapering Arm | 0.1 swollen joint counts | Standard Deviation 0.64 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 34- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.46 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 22- Withdrawal arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 28 | Double Blind Week 40- Withdrawal Arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
Secondary
Mean Change From Double-blind Baseline in Swollen Joint Count 66
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 16- Withdrawal Arm | 0.4 swollen joint counts | Standard Deviation 0.74 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 34- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.43 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 34- Withdrawal Arm | 0.0 swollen joint counts | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 40- Tapering Arm | 1.5 swollen joint counts | Standard Deviation 3.01 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 40- Withdrawal Arm | 2.0 swollen joint counts | Standard Deviation 2.83 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 0- Tapering Arm | 2.6 swollen joint counts | Standard Deviation 2.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 0- Withdrawal Arm | 2.6 swollen joint counts | Standard Deviation 3.38 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 4- Tapering Arm | 1.3 swollen joint counts | Standard Deviation 1.99 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 4- Withdrawal Arm | 0.6 swollen joint counts | Standard Deviation 1.06 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 10- Tapering Arm | 0.6 swollen joint counts | Standard Deviation 1.1 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 10- Withdrawal Arm | 0.4 swollen joint counts | Standard Deviation 0.52 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Flare Week 16- Tapering Arm | 1.1 swollen joint counts | Standard Deviation 2.21 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 10- Tapering Arm | 1.1 swollen joint counts | Standard Deviation 2.36 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 10- Withdrawal Arm | 0.1 swollen joint counts | Standard Deviation 0.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 16- Tapering Arm | 1.4 swollen joint counts | Standard Deviation 2.56 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 16- Withdrawal Arm | 0.4 swollen joint counts | Standard Deviation 0.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 22- Tapering Arm | 0.6 swollen joint counts | Standard Deviation 1.64 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 22- Withdrawal arm | 1.0 swollen joint counts | Standard Deviation 1.41 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 28- Tapering arm | 0.5 swollen joint counts | Standard Deviation 0.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 28- Withdrawal Arm | 3.3 swollen joint counts | Standard Deviation 4.72 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 10- Tapering Arm | 0.1 swollen joint counts | Standard Deviation 0.67 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 28- Tapering arm | 0.1 swollen joint counts | Standard Deviation 0.66 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 10- Withdrawal Arm | -0.2 swollen joint counts | Standard Deviation 0.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 34- Withdrawal Arm | -0.2 swollen joint counts | Standard Deviation 0.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 16- Tapering Arm | -0.0 swollen joint counts | Standard Deviation 0.34 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 28- Withdrawal Arm | -0.2 swollen joint counts | Standard Deviation 0.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 16- Withdrawal Arm | 0.0 swollen joint counts | Standard Deviation 0.45 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 40- Withdrawal Arm | -0.2 swollen joint counts | Standard Deviation 0.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 22- Tapering Arm | 0.1 swollen joint counts | Standard Deviation 0.73 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 34- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.54 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 22- Withdrawal arm | -0.1 swollen joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Swollen Joint Count 66 | Double Blind Week 40- Tapering Arm | 0.0 swollen joint counts | Standard Deviation 0.46 |
Secondary
Mean Change From Double-blind Baseline in Tender Joint Count 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 16- Withdrawal Arm | 1.1 tender joint counts | Standard Deviation 1.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 34- Tapering Arm | 1.0 tender joint counts | Standard Deviation 1.65 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 34- Withdrawal Arm | 0.0 tender joint counts | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 40- Tapering Arm | 2.0 tender joint counts | Standard Deviation 2.65 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 40- Withdrawal Arm | 3.5 tender joint counts | Standard Deviation 4.95 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 0- Tapering Arm | 4.4 tender joint counts | Standard Deviation 4.63 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 0- Withdrawal Arm | 3.6 tender joint counts | Standard Deviation 3.81 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 4- Tapering Arm | 1.5 tender joint counts | Standard Deviation 2.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 4- Withdrawal Arm | 2.5 tender joint counts | Standard Deviation 5.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 10- Tapering Arm | 0.9 tender joint counts | Standard Deviation 1.84 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 10- Withdrawal Arm | 1.1 tender joint counts | Standard Deviation 1.46 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Flare Week 16- Tapering Arm | 1.8 tender joint counts | Standard Deviation 2.64 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 10- Tapering Arm | 1.3 tender joint counts | Standard Deviation 2.74 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 10- Withdrawal Arm | -0.1 tender joint counts | Standard Deviation 0.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 16- Tapering Arm | 2.5 tender joint counts | Standard Deviation 4.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 16- Withdrawal Arm | 1.0 tender joint counts | Standard Deviation 0.87 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 22- Tapering Arm | 0.9 tender joint counts | Standard Deviation 1.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 22- Withdrawal arm | 0.8 tender joint counts | Standard Deviation 1.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 28- Tapering arm | 1.6 tender joint counts | Standard Deviation 3.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 28- Withdrawal Arm | 1.8 tender joint counts | Standard Deviation 2.36 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 10- Tapering Arm | 0.1 tender joint counts | Standard Deviation 0.54 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 28- Tapering arm | 0.0 tender joint counts | Standard Deviation 0.51 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 10- Withdrawal Arm | 0.5 tender joint counts | Standard Deviation 1.21 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 34- Withdrawal Arm | 0.0 tender joint counts | Standard Deviation 0 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 16- Tapering Arm | 0.1 tender joint counts | Standard Deviation 0.41 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 28- Withdrawal Arm | 0.2 tender joint counts | Standard Deviation 0.4 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 16- Withdrawal Arm | 0.0 tender joint counts | Standard Deviation 0 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 40- Withdrawal Arm | 0.0 tender joint counts | Standard Deviation 0 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 22- Tapering Arm | -0.0 tender joint counts | Standard Deviation 0.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 34- Tapering Arm | -0.0 tender joint counts | Standard Deviation 0.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 22- Withdrawal arm | 0.1 tender joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 28 | Double Blind Week 40- Tapering Arm | 0.0 tender joint counts | Standard Deviation 0.51 |
Secondary
Mean Change From Double-blind Baseline in Tender Joint Count 68
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 16- Withdrawal Arm | 1.6 tender joint counts | Standard Deviation 1.85 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 34- Tapering Arm | 1.9 tender joint counts | Standard Deviation 2.87 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 34- Withdrawal Arm | 0.0 tender joint counts | Standard Deviation 0 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 40- Tapering Arm | 3.0 tender joint counts | Standard Deviation 4.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 40- Withdrawal Arm | 9.0 tender joint counts | Standard Deviation 12.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 0- Tapering Arm | 6.2 tender joint counts | Standard Deviation 6.93 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 0- Withdrawal Arm | 6.1 tender joint counts | Standard Deviation 6.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 4- Tapering Arm | 1.9 tender joint counts | Standard Deviation 2.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 4- Withdrawal Arm | 4.1 tender joint counts | Standard Deviation 8.48 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 10- Tapering Arm | 1.5 tender joint counts | Standard Deviation 2.69 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 10- Withdrawal Arm | 2.3 tender joint counts | Standard Deviation 2.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Flare Week 16- Tapering Arm | 2.1 tender joint counts | Standard Deviation 3.37 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 10- Tapering Arm | 1.9 tender joint counts | Standard Deviation 3.45 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 10- Withdrawal Arm | 0.1 tender joint counts | Standard Deviation 0.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 16- Tapering Arm | 3.5 tender joint counts | Standard Deviation 6.33 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 16- Withdrawal Arm | 1.4 tender joint counts | Standard Deviation 1.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 22- Tapering Arm | 1.2 tender joint counts | Standard Deviation 2.27 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 22- Withdrawal arm | 2.0 tender joint counts | Standard Deviation 2.83 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 28- Tapering arm | 2.5 tender joint counts | Standard Deviation 5.34 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 28- Withdrawal Arm | 3.8 tender joint counts | Standard Deviation 4.5 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 10- Tapering Arm | 0.3 tender joint counts | Standard Deviation 1.47 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 28- Tapering arm | 0.1 tender joint counts | Standard Deviation 0.96 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 10- Withdrawal Arm | 0.9 tender joint counts | Standard Deviation 1.64 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 34- Withdrawal Arm | 0.1 tender joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 16- Tapering Arm | 0.2 tender joint counts | Standard Deviation 1.36 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 28- Withdrawal Arm | 0.3 tender joint counts | Standard Deviation 0.47 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 16- Withdrawal Arm | 0.2 tender joint counts | Standard Deviation 0.6 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 40- Withdrawal Arm | -0.1 tender joint counts | Standard Deviation 0.3 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 22- Tapering Arm | 0.2 tender joint counts | Standard Deviation 1.35 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 34- Tapering Arm | 0.0 tender joint counts | Standard Deviation 0.73 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 22- Withdrawal arm | 0.4 tender joint counts | Standard Deviation 1.03 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Tender Joint Count 68 | Double Blind Week 40- Tapering Arm | 0.0 tender joint counts | Standard Deviation 0.68 |
Secondary
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 16- Tapering Arm | -0.2 units on a scale | Standard Deviation 16.96 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 40- Withdrawal Arm | -16.7 units on a scale | Standard Deviation 23.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 4- Withdrawal Arm | 5.6 units on a scale | Standard Deviation 18.92 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 10- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 16.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 0- Tapering Arm | 4.2 units on a scale | Standard Deviation 12.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 0- Withdrawal Arm | -7.1 units on a scale | Standard Deviation 14.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 4- Tapering Arm | 4.4 units on a scale | Standard Deviation 19.84 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 10- Tapering Arm | 1.2 units on a scale | Standard Deviation 10.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 16- Tapering Arm | 1.6 units on a scale | Standard Deviation 19.65 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Flare Week 16- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 20.89 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 16- Withdrawal Arm | -4.9 units on a scale | Standard Deviation 19.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 28- Tapering arm | 0.0 units on a scale | Standard Deviation 18.7 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 28- Withdrawal Arm | -4.2 units on a scale | Standard Deviation 12.32 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 40- Tapering Arm | -4.0 units on a scale | Standard Deviation 9.65 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 16- Tapering Arm | 0.8 units on a scale | Standard Deviation 13.45 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 28- Withdrawal Arm | -3.5 units on a scale | Standard Deviation 13.21 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 16- Withdrawal Arm | 4.0 units on a scale | Standard Deviation 10.86 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 40- Withdrawal Arm | 2.5 units on a scale | Standard Deviation 18.32 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 28- Tapering arm | -1.0 units on a scale | Standard Deviation 15.47 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score | Double Blind Week 40- Tapering Arm | -0.1 units on a scale | Standard Deviation 16.5 |
Secondary
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 16- Withdrawal Arm | 2.8 units on a scale | Standard Deviation 39.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 4- Withdrawal Arm | -6.5 units on a scale | Standard Deviation 48.23 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 16- Tapering Arm | -8.3 units on a scale | Standard Deviation 35.3 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 0- Withdrawal Arm | -9.5 units on a scale | Standard Deviation 38.05 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 4- Tapering Arm | -17.3 units on a scale | Standard Deviation 40.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 10- Tapering Arm | -10.7 units on a scale | Standard Deviation 44.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 10- Withdrawal Arm | 7.9 units on a scale | Standard Deviation 34.23 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 16- Tapering Arm | -7.5 units on a scale | Standard Deviation 25.49 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 16- Withdrawal Arm | -16.7 units on a scale | Standard Deviation 39.67 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 28- Tapering arm | -10.1 units on a scale | Standard Deviation 24.28 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 28- Withdrawal Arm | -5.6 units on a scale | Standard Deviation 45.59 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 40- Tapering Arm | -15.2 units on a scale | Standard Deviation 33.53 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 40- Withdrawal Arm | -19.4 units on a scale | Standard Deviation 27.5 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Flare Week 0- Tapering Arm | -10.9 units on a scale | Standard Deviation 39.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 16- Tapering Arm | 0.2 units on a scale | Standard Deviation 23.74 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 16- Withdrawal Arm | -13.6 units on a scale | Standard Deviation 43.84 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 40- Withdrawal Arm | -16.2 units on a scale | Standard Deviation 45.1 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 28- Tapering arm | -3.8 units on a scale | Standard Deviation 17.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 40- Tapering Arm | -4.4 units on a scale | Standard Deviation 27.82 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score | Double Blind Week 28- Withdrawal Arm | -17.2 units on a scale | Standard Deviation 30.48 |
Secondary
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 16- Withdrawal Arm | -8.2 units on a scale | Standard Deviation 16.72 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 40- Tapering Arm | -3.2 units on a scale | Standard Deviation 13.31 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 16- Tapering Arm | -11.6 units on a scale | Standard Deviation 24.99 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 0- Withdrawal Arm | -9.2 units on a scale | Standard Deviation 25.66 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 4- Tapering Arm | -3.1 units on a scale | Standard Deviation 20.32 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 4- Withdrawal Arm | -1.2 units on a scale | Standard Deviation 24.08 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 10- Tapering Arm | -0.8 units on a scale | Standard Deviation 13.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 10- Withdrawal Arm | -2.0 units on a scale | Standard Deviation 18.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 16- Tapering Arm | -6.6 units on a scale | Standard Deviation 24.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 16- Withdrawal Arm | -2.7 units on a scale | Standard Deviation 15.24 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 28- Tapering arm | -2.2 units on a scale | Standard Deviation 12.7 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 28- Withdrawal Arm | 5.4 units on a scale | Standard Deviation 15.84 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 40- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 10.1 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Flare Week 0- Tapering Arm | -11.7 units on a scale | Standard Deviation 27.58 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 16- Tapering Arm | -3.4 units on a scale | Standard Deviation 17.91 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 40- Tapering Arm | -2.6 units on a scale | Standard Deviation 15.1 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 16- Withdrawal Arm | 0.6 units on a scale | Standard Deviation 22.69 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 28- Withdrawal Arm | -4.5 units on a scale | Standard Deviation 25.81 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 28- Tapering arm | -5.7 units on a scale | Standard Deviation 14.97 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score | Double Blind Week 40- Withdrawal Arm | -3.2 units on a scale | Standard Deviation 21.98 |
Secondary
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 16- Withdrawal Arm | 2.7 units on a scale | Standard Deviation 7.09 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 16- Tapering Arm | -8.0 units on a scale | Standard Deviation 17.25 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 0- Withdrawal Arm | 2.7 units on a scale | Standard Deviation 7.09 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 4- Tapering Arm | -5.0 units on a scale | Standard Deviation 19.52 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 4- Withdrawal Arm | 3.1 units on a scale | Standard Deviation 7.65 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 10- Tapering Arm | -3.7 units on a scale | Standard Deviation 13.9 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 10- Withdrawal Arm | 2.7 units on a scale | Standard Deviation 7.09 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 16- Tapering Arm | -2.0 units on a scale | Standard Deviation 6.6 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 16- Withdrawal Arm | 9.4 units on a scale | Standard Deviation 20.04 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 28- Tapering arm | -2.7 units on a scale | Standard Deviation 12.28 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 28- Withdrawal Arm | 14.1 units on a scale | Standard Deviation 28.13 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 40- Tapering Arm | -2.3 units on a scale | Standard Deviation 14.86 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 40- Withdrawal Arm | 28.1 units on a scale | Standard Deviation 39.77 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Flare Week 0- Tapering Arm | -5.1 units on a scale | Standard Deviation 15.96 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 16- Tapering Arm | -0.5 units on a scale | Standard Deviation 11.26 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 28- Withdrawal Arm | 2.8 units on a scale | Standard Deviation 9.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 16- Withdrawal Arm | 2.8 units on a scale | Standard Deviation 9.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 40- Withdrawal Arm | 2.8 units on a scale | Standard Deviation 9.42 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 28- Tapering arm | 1.1 units on a scale | Standard Deviation 7.44 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score | Double Blind Week 40- Tapering Arm | 1.1 units on a scale | Standard Deviation 11.61 |
Secondary
Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 28- Tapering Arm | 15.0 percent impairment | Standard Deviation 21.21 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare Wk 10- Tapering Arm | -0.2 percent impairment | Standard Deviation 8.78 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare W 10- Withdrawal Arm | 5.0 percent impairment | Standard Deviation 7.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare Wk 10- Tapering Arm | 6.5 percent impairment | Standard Deviation 15.48 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare W 10- Withdrawal Arm | 12.9 percent impairment | Standard Deviation 13.8 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare Wk 16- Tapering Arm | 10.0 percent impairment | Standard Deviation 14.82 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare W 16- Withdrawal Arm | 10.0 percent impairment | Standard Deviation 10 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare Wk 16- Tapering Arm | 11.0 percent impairment | Standard Deviation 17.39 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare Wk 16- Withdrawal Arm | 8.8 percent impairment | Standard Deviation 11.26 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 28- Withdrawal Arm | 0.0 percent impairment | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 28- Tapering arm | 5.0 percent impairment | Standard Deviation 19.51 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 28- Withdrawal Arm | 10.0 percent impairment | Standard Deviation 17.32 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 40- Tapering arm | 15.7 percent impairment | Standard Deviation 9.76 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 40- Withdrawal Arm | 20.0 percent impairment | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare Wk 0- Tapering Arm | 14.0 percent impairment | Standard Deviation 27.02 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment Flare Wk 0- Withdrawal Arm | 5.0 percent impairment | Standard Deviation 7.07 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare Week 0- Tapering Arm | 25.9 percent impairment | Standard Deviation 31.57 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment Flare Week 0- Withdrawal Arm | 8.0 percent impairment | Standard Deviation 25.88 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 28- Tapering Arm | 3.5 percent impairment | Standard Deviation 10.68 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 40- Withdrawal Arm | 0.6 percent impairment | Standard Deviation 8.12 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 28- Withdrawal Arm | 0.6 percent impairment | Standard Deviation 8.12 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 40- Withdrawal Arm | 0.0 percent impairment | Standard Deviation 6.32 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 28- Tapering arm | 2.8 percent impairment | Standard Deviation 13.43 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 40- Tapering arm | 0.5 percent impairment | Standard Deviation 13.59 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Activity Impairment at Week 28- Withdrawal Arm | -0.9 percent impairment | Standard Deviation 7.01 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores | Overall Work Impairment at Week 40- Tapering Arm | 3.4 percent impairment | Standard Deviation 18.78 |
Secondary
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Double Blind Week 40- Tapering Arm | -0.5 units on a scale | Standard Deviation 1.73 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Double Blind Week 40- Withdrawal Arm | -2.0 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Flare Week 16- Tapering Arm | 0.3 units on a scale | Standard Deviation 1.02 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Flare Week 16- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 0.88 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Double Blind Week 40- Tapering Arm | 0.1 units on a scale | Standard Deviation 0.52 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score | Double Blind Week 40- Withdrawal Arm | 0.0 units on a scale | Standard Deviation 1.08 |
Secondary
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Double Blind Week 40- Withdrawal Arm | 0.0 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Flare Week 16- Tapering Arm | -0.1 units on a scale | Standard Deviation 0.47 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Double Blind Week 40- Tapering Arm | -0.5 units on a scale | Standard Deviation 0.84 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Flare Week 16- Withdrawal Arm | 0.3 units on a scale | Standard Deviation 0.38 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Double Blind Week 40- Withdrawal Arm | 1.2 units on a scale | Standard Deviation 3.52 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score | Double Blind Week 40- Tapering Arm | 0.0 units on a scale | Standard Deviation 1.07 |
Secondary
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Double Blind Week 40- Tapering Arm | -0.1 units on a scale | Standard Deviation 1.2 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Double Blind Week 40- Withdrawal Arm | 0.0 units on a scale | — |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Flare Week 16- Tapering Arm | 0.8 units on a scale | Standard Deviation 1.84 |
| Adalimumab Tapering | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Flare Week 16- Withdrawal Arm | 0.1 units on a scale | Standard Deviation 1.81 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Double Blind Week 40- Tapering Arm | 0.1 units on a scale | Standard Deviation 1.33 |
| Adalimumab Withdrawal Arm | Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score | Double Blind Week 40- Withdrawal Arm | -0.1 units on a scale | Standard Deviation 0.9 |
Secondary
Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home
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
Population: All Open-label rescue treated participants with available data; last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 2- Tapering Arm | -3.1 units on a scale | Standard Deviation 5.41 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 3- Tapering Arm | -3.8 units on a scale | Standard Deviation 6.78 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 1- Tapering Arm | -1.6 units on a scale | Standard Deviation 4.92 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 1- Withdrawal Arm | 3.7 units on a scale | Standard Deviation 7.2 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 2- Withdrawal Arm | 0.8 units on a scale | Standard Deviation 6.89 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 3- Withdrawal Arm | -0.4 units on a scale | Standard Deviation 7.94 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 5- Tapering Arm | -3.8 units on a scale | Standard Deviation 6.61 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 5- Withdrawal Arm | -0.8 units on a scale | Standard Deviation 6.56 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 6- Tapering Arm | -4.1 units on a scale | Standard Deviation 6.81 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 6- Withdrawal Arm | -0.9 units on a scale | Standard Deviation 6.97 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 7- Tapering Arm | -3.7 units on a scale | Standard Deviation 6.86 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 7- Withdrawal Arm | -0.6 units on a scale | Standard Deviation 6.26 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 8- Tapering Arm | -4.4 units on a scale | Standard Deviation 7.17 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 8- Withdrawal Arm | -0.6 units on a scale | Standard Deviation 5.56 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 9- Tapering Arm | -3.3 units on a scale | Standard Deviation 5.81 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 9- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 5.89 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 11- Tapering Arm | -3.7 units on a scale | Standard Deviation 5.69 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 11- Withdrawal Arm | -1.0 units on a scale | Standard Deviation 5.85 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 12- Tapering Arm | -3.4 units on a scale | Standard Deviation 5.84 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 12- Withdrawal Arm | -2.3 units on a scale | Standard Deviation 4.46 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 13- Tapering Arm | -3.5 units on a scale | Standard Deviation 5.72 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 13- Withdrawal Arm | -2.5 units on a scale | Standard Deviation 4.78 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 14- Tapering Arm | -3.1 units on a scale | Standard Deviation 5.54 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 14- Withdrawal Arm | -2.4 units on a scale | Standard Deviation 4.79 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 15- Tapering Arm | -3.5 units on a scale | Standard Deviation 6.69 |
| Adalimumab Tapering | Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home | Flare Week 15- Withdrawal Arm | -2.2 units on a scale | Standard Deviation 4.7 |
Secondary
Median Time to Clinical Remission From the Occurrence of Flare
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
Population: All Open-label rescue treated participants excluding those who incorrectly entered the Open-label Rescue Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adalimumab Tapering | Median Time to Clinical Remission From the Occurrence of Flare | 6.1 weeks |
| Adalimumab Withdrawal Arm | Median Time to Clinical Remission From the Occurrence of Flare | 18.0 weeks |
Secondary
Median Time to Flare
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
Population: Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adalimumab Tapering | Median Time to Flare | NA weeks |
| Adalimumab Withdrawal Arm | Median Time to Flare | NA weeks |
Secondary
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
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab Tapering | 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 | Double Blind Week 22- Withdrawal Arm | 14 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 10- Tapering Arm | 85 Participants |
| Adalimumab Tapering | 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 | Flare Week 0- Withdrawal Arm | 1 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 28- Tapering Arm | 69 Participants |
| Adalimumab Tapering | 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 | Flare Week 16- Tapering Arm | 13 Participants |
| Adalimumab Tapering | 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 | Flare Week 0- Tapering Arm | 4 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 28- Withdrawal Arm | 13 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 10- Withdrawal Arm | 18 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 40- Tapering Arm | 64 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 34- Tapering Arm | 70 Participants |
| Adalimumab Tapering | 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 | Double Blind Baseline- Withdrawal Arm | 20 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 34- Withdrawal Arm | 13 Participants |
| Adalimumab Tapering | 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 | Flare Week 10- Withdrawal Arm | 3 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 16- Tapering Arm | 78 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 40- Withdrawal Arm | 11 Participants |
| Adalimumab Tapering | 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 | Flare Week 10- Tapering Arm | 17 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 16- Withdrawal arm | 15 Participants |
| Adalimumab Tapering | 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 | Double Blind Baseline- Tapering Arm | 102 Participants |
| Adalimumab Tapering | 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 | Flare Week 4- Withdrawal Arm | 1 Participants |
| Adalimumab Tapering | 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 | Double Blind Week 22- Tapering Arm | 75 Participants |
| Adalimumab Tapering | 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 | Flare Week 16- Withdrawal Arm | 4 Participants |
| Adalimumab Tapering | 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 | Flare Week 4- Tapering Arm | 14 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Baseline- Withdrawal Arm | 19 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 40- Withdrawal Arm | 12 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 16- Tapering Arm | 13 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 10- Tapering Arm | 63 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 10- Withdrawal Arm | 16 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 16- Tapering Arm | 64 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 16- Withdrawal arm | 13 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 22- Tapering Arm | 59 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 22- Withdrawal Arm | 13 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 28- Tapering Arm | 58 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 28- Withdrawal Arm | 12 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 34- Tapering Arm | 58 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 34- Withdrawal Arm | 13 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Week 40- Tapering Arm | 57 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 0- Tapering Arm | 4 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 0- Withdrawal Arm | 0 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 4- Tapering Arm | 13 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 4- Withdrawal Arm | 2 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 10- Tapering Arm | 14 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 10- Withdrawal Arm | 2 Participants |
| Adalimumab Withdrawal Arm | 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 | Flare Week 16- Withdrawal Arm | 4 Participants |
| Adalimumab Withdrawal Arm | 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 | Double Blind Baseline- Tapering Arm | 89 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 40- Withdrawal Arm | 12 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 0- Withdrawal Arm | 2 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 22- Tapering Arm | 58 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 16- Withdrawal Arm | 4 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 4- Tapering Arm | 13 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 16- Withdrawal arm | 15 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 16- Tapering Arm | 13 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 4- Withdrawal Arm | 2 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 16- Tapering Arm | 62 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Baseline- Withdrawal Arm | 19 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 10- Tapering Arm | 14 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 10- Withdrawal Arm | 14 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 34- Tapering Arm | 58 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Baseline- Tapering Arm | 85 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 34- Withdrawal Arm | 13 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 28- Withdrawal Arm | 13 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 10- Withdrawal Arm | 2 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 40- Tapering Arm | 56 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 28- Tapering Arm | 57 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 10- Tapering Arm | 62 Participants |
| CDAI ≤ 2.8 | 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 | Flare Week 0- Tapering Arm | 4 Participants |
| CDAI ≤ 2.8 | 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 | Double Blind Week 22- Withdrawal Arm | 13 Participants |
Secondary
Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time
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
Population: All Open-label rescue-treated participants excluding those who incorrectly entered the Open-label Rescue Period; last observation carried forward
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab Tapering | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 0 | 3 Participants |
| Adalimumab Tapering | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 4 | 14 Participants |
| Adalimumab Tapering | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 10 | 17 Participants |
| Adalimumab Tapering | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 16 | 13 Participants |
| Adalimumab Withdrawal Arm | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 16 | 4 Participants |
| Adalimumab Withdrawal Arm | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 0 | 1 Participants |
| Adalimumab Withdrawal Arm | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 10 | 3 Participants |
| Adalimumab Withdrawal Arm | Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time | Flare Week 4 | 1 Participants |
Secondary
Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab Tapering | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 4- Tapering Arm | 21 Participants |
| Adalimumab Tapering | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 4- Withdrawal Arm | 7 Participants |
| Adalimumab Tapering | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 40- Tapering Arm | 2 Participants |
| Adalimumab Tapering | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 40- Withdrawal Arm | 0 Participants |
| Adalimumab Withdrawal Arm | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 40- Withdrawal Arm | 9 Participants |
| Adalimumab Withdrawal Arm | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 4- Tapering Arm | 50 Participants |
| Adalimumab Withdrawal Arm | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 40- Tapering Arm | 48 Participants |
| Adalimumab Withdrawal Arm | Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40 | Double Blind Week 4- Withdrawal Arm | 10 Participants |
Secondary
Participants' Assessment of Flare Severity
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
Population: All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 1 | 2 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 6 | 4 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 3 | 3 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 7 | 1 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 0 | 1 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 8 | 2 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 4 | 4 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 9 | 0 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 2 | 2 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 5 | 1 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | Missing | 8 Participants |
| Adalimumab Tapering | Participants' Assessment of Flare Severity | 10 | 2 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | Missing | 3 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 0 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 1 | 1 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 2 | 2 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 3 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 4 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 5 | 1 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 6 | 1 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 7 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 8 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 9 | 0 Participants |
| Adalimumab Withdrawal Arm | Participants' Assessment of Flare Severity | 10 | 0 Participants |
Secondary
Percentage of Participants With a Flare
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
Population: Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Tapering | Percentage of Participants With a Flare | 36.3 percentage of participants |
| Adalimumab Withdrawal Arm | Percentage of Participants With a Flare | 45.0 percentage of participants |
Secondary
Physicians' Assessment of Flare Severity
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
Population: All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 0 | 1 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 1 | 2 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 2 | 3 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 3 | 3 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 4 | 6 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 5 | 1 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 6 | 4 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 7 | 1 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 8 | 0 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 9 | 0 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | 10 | 0 Participants |
| Adalimumab Tapering | Physicians' Assessment of Flare Severity | Missing | 9 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 10 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 0 | 1 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 6 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 1 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 9 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 2 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 7 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 3 | 1 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | Missing | 3 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 4 | 2 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 8 | 0 Participants |
| Adalimumab Withdrawal Arm | Physicians' Assessment of Flare Severity | 5 | 1 Participants |