Arthritis, Rheumatoid
Conditions
Keywords
adalimumab,Remission,drug discontinuation
Brief summary
The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.
Detailed description
Treatments with adalimumab and other tumor necrosis factor (TNF) blockers, once started as therapy for rheumatoid arthritis (RA), are usually continued indefinitely. Information concerning the possibility of discontinuing anti-TNF therapy in RA patients who are in remission is limited. This is a pilot study in one country to study the effect of adalimumab discontinuation. The objective is to assess the proportion of patients with established RA in stable remission (Disease Activity Score \[DAS\]28 \<2.6) after treatment with adalimumab in combination with methotrexate, in whom it is possible to discontinue adalimumab and to compare the remission rates among patients on sustained therapy with adalimumab + methotrexate with remission rates among patients who discontinued adalimumab. Rheumatoid arthritis patients in stable remission (DAS28 \< 2.6) treated with adalimumab + methotrexate were randomized in a 1:1 ratio to continue with adalimumab treatment or discontinue adalimumab treatment for the following 52 weeks. Subsequently an observational extension was conducted to observe patients treated at the discretion of the investigator. The observational extension period lasted until Weeks 105 - 156 (average Week 125) and consisted of one follow-up visit. Participants randomized to discontinue adalimumab therapy will be reinstituted to adalimumab if DAS28-score increases by \>1.2 units from baseline and/or is scored ≥2.6 at any visit during the study and will be followed for an additional 12 weeks.
Interventions
BIOLOGICALadalimumab
40 mg every other week via subcutaneous injection
DRUGmethotrexate
At least 10 mg/week administered orally or subcutaneously
Sponsors
Pharma Consulting Group AB
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Diagnosis of RA as defined by the 1987-revised American College of Rheumatology (ACR)-classification and has positive rheumatoid factor (RF) test or erosion on X-ray of hands or feet. * Currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously). * In remission as defined by disease activity score (DAS)28 \<2.6 for at least the past 3 months. * Concomitant disease-modifying anti-rheumatic drug (DMARD) or oral corticosteroid therapy has been stable for at least 3 months at study entry. * Female subject is either not of childbearing potential or is practicing a relevant method of birth control. * Subject is judged to be in good general health. * Subjects must be able and willing to provide written informed consent. * Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Exclusion criteria
* Treatment with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks. * Oral prednisone or prednisone equivalent \> 10 mg/day at baseline. * Joint surgery within the preceding two months. * History of acute inflammatory joint disease other than RA. * Treatment with any investigational drug within 30 days or 5 half lives, whichever is longer prior to study entry. * Poorly controlled medical condition, which would put the subject at risk by participation in the study. * History of clinically significant hematologic, renal or liver disease. * Diagnosis of, or history suggestive of, central nervous system (CNS) demyelinating disease. * History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma of the cervix. * History of listeriosis, histoplasmosis, untreated tuberculosis (TB), persistent chronic infections, or recent active infections. * Known immune deficiency or human immunodeficiency virus (HIV). * Female who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Remission at Week 28 | Week 28 | Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission. |
| Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) | Week 28 | Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Flare | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52 | Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. |
| Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare | 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy | For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. |
| Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare | 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy | For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. |
| Health Assessment Questionnaire (HAQ) Total Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-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. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. |
| European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state: Level 1: I have no problems in walking about; Level 2: I have some problems in walking about; Level 3: I am confined to bed. |
| European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state: Level 1: I have no problems with self-care; Level 2: I have some problems washing or dressing myself; Level 3: I am unable to wash or dress myself. |
| European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities): Level 1: I have no problems performing my usual activities; Level 2: I have some problems performing my usual activities; Level 3: I am unable to perform my usual activities. |
| European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state: Level 1: I have no pain or discomfort; Level 2: I have moderate pain or discomfort; Level 3: I have extreme pain or discomfort. |
| European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state: Level 1: I am not anxious or depressed; Level 2: I am moderately anxious or depressed; Level 3: I am extremely anxious or depressed. |
| European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100). |
| Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit) | The FACIT-Fatigue questionnaire is a self-administered patient 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. |
| Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis. |
| Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work. |
| Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage. |
| Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare. |
| Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem. |
| Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work. |
| Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower. |
| Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work. |
| Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working. |
| Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work. |
| Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to. |
| Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave. |
| Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis. |
| Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day. |
| Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work. |
| Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work. |
| Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work. |
| Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs. |
| Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work. |
| Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work. |
| Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain. |
| Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind. |
| Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline and at Weeks 12, 28, 52, and 104-156 | Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do. |
| Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline and at Weeks 12, 28, 52, and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No). |
| Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Baseline and at Weeks 12, 28, 52, and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis. |
| Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Baseline and at Weeks 12, 28, 52, and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis. |
| Percentage of Participants in Remission at Week 52 | Week 52 | Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission. |
| Work Productivity and Activity Impairment (WPAI): Work Productivity | Baseline and at Weeks 12, 28, 52, and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working). |
| Work Productivity and Activity Impairment (WPAI): Daily Activities | Baseline and at Weeks 12, 28, 52, and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities). |
| Change From Baseline in Radiological Modified Total Sharp Score | Baseline, Week 52, and Weeks 104-156 | The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. |
| Work Productivity and Activity Impairment (WPAI): Hours Worked | Baseline and at Weeks 12, 28, 52 and 104-156 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days. |
| Percentage of Participants in Remission at Week 52 (FAS2) | Week 52 | Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. |
Countries
Sweden
Participant flow
Recruitment details
Patients with rheumatoid arthritis (RA) treated with adalimumab plus methotrexate and in remission for at least the past 3 months were enrolled from 8 investigative sites in Sweden.
Pre-assignment details
Participants were randomized to continue or discontinue adalimumab treatment for 52 weeks. After the final visit an observational extension period ensued where patients were treated at the discretion of the investigator. The observational extension period lasted until a follow-up visit scheduled at Weeks 104 - 156 (average Week 125).
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab + MTX Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator. | 17 |
| Methotrexate Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator. | 16 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomized Phase | Did not meet eligibility criteria | 1 | 0 |
| Randomized Phase | Patient refused rescue therapy | 0 | 3 |
| Randomized Phase | Reduced methotrexate dose | 1 | 2 |
Baseline characteristics
| Characteristic | Adalimumab + MTX | Methotrexate | Total |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 13 | 61.3 years STANDARD_DEVIATION 9.9 | 56.8 years STANDARD_DEVIATION 12.2 |
| Disease Activity Score (DAS) 28 | 1.98 units on a scale STANDARD_DEVIATION 0.48 | 1.73 units on a scale STANDARD_DEVIATION 0.61 | 1.86 units on a scale STANDARD_DEVIATION 0.55 |
| Disease duration | 10.4 years STANDARD_DEVIATION 8.9 | 13.2 years STANDARD_DEVIATION 12.5 | 11.7 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Sweden | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 17 | 7 / 7 | 8 / 9 | 15 / 16 |
| serious Total, serious adverse events | 1 / 17 | 0 / 7 | 3 / 9 | 3 / 16 |
Outcome results
Primary
Percentage of Participants in Remission at Week 28
Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.
Time frame: Week 28
Population: Full analysis set (FAS), defined as all participants who received at least one dose of adalimumab and/or methotrexate and had at least one post-baseline observation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab + MTX | Percentage of Participants in Remission at Week 28 | 87.5 percentage of participants |
| Methotrexate | Percentage of Participants in Remission at Week 28 | 18.8 percentage of participants |
Primary
Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)
Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.
Time frame: Week 28
Population: Full analysis set 2 (FAS2), defined as participants in the full analysis set who completed at least 28 weeks of the study or completed the study until flare, whichever occurs first.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab + MTX | Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) | 87.5 percentage of participants |
| Methotrexate | Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) | 20.0 percentage of participants |
Secondary
Change From Baseline in Radiological Modified Total Sharp Score
The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Time frame: Baseline, Week 52, and Weeks 104-156
Population: Full analysis set; N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Change From Baseline in Radiological Modified Total Sharp Score | Change at Week 52 (N=16, 11) | 0.1 units on a scale | Standard Deviation 9.4 |
| Adalimumab + MTX | Change From Baseline in Radiological Modified Total Sharp Score | Change at Week 104-156 (N=16, 13) | -2.4 units on a scale | Standard Deviation 20.9 |
| Methotrexate | Change From Baseline in Radiological Modified Total Sharp Score | Change at Week 52 (N=16, 11) | -0.8 units on a scale | Standard Deviation 13.5 |
| Methotrexate | Change From Baseline in Radiological Modified Total Sharp Score | Change at Week 104-156 (N=16, 13) | -7.2 units on a scale | Standard Deviation 15.7 |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state: Level 1: I am not anxious or depressed; Level 2: I am moderately anxious or depressed; Level 3: I am extremely anxious or depressed.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 1 | 11 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 2 | 4 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 1 | 11 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 2 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 1 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 1 | 6 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 2 | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Baseline: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Missing | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 1 | 10 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 2 | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Missing | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 28: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 4: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 1 | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 1 | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 1 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 8: Missing | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 1 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 1 | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 2 | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 36: Missing | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 12: Missing | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 1 | 6 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 52: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 44: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit | Week 20: Missing | 8 participants |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state: Level 1: I have no problems in walking about; Level 2: I have some problems in walking about; Level 3: I am confined to bed.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 1 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 1 | 11 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 2 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 1 | 11 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 2 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 2 | 4 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 2 | 4 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 1 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 2 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 1 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 2 | 6 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 1 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 2 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 2 | 4 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Missing | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Missing | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 1 | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 2 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 4: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 1 | 10 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 2 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 8: Missing | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 1 | 10 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 12: Missing | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 1 | 6 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 20: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 1 | 7 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 28: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 1 | 5 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 36: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 1 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 44: Missing | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Week 52: Missing | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 1 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Weeks 104-156: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 1 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit | Baseline: Level 2 | 2 participants |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state: Level 1: I have no pain or discomfort; Level 2: I have moderate pain or discomfort; Level 3: I have extreme pain or discomfort.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 2 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 1 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 2 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 1 | 7 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 2 | 9 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 1 | 6 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 1 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 2 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 1 | 7 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 2 | 9 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 1 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 2 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 1 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 2 | 7 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 1 | 7 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 2 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 1 | 5 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 2 | 10 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 1 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 2 | 8 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 2 | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 1 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 1 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 2 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 2 | 5 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Baseline: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Missing | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 2 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Missing | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 28: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 4: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 1 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 1 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 2 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 1 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 2 | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 8: Missing | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 1 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 1 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 2 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 36: Missing | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 12: Missing | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 1 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 1 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 2 | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 52: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 44: Level 2 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit | Week 20: Missing | 8 participants |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state: Level 1: I have no problems with self-care; Level 2: I have some problems washing or dressing myself; Level 3: I am unable to wash or dress myself.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 2 | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 1 | 16 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 1 | 16 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 1 | 15 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 1 | 15 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 2 | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 1 | 16 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 2 | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 1 | 15 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 2 | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 1 | 15 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 1 | 16 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 2 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 1 | 16 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 1 | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Baseline: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Missing | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 1 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Missing | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Level 3 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 28: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 4: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 1 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 1 | 5 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 8: Missing | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 1 | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 1 | 9 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 2 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Level 3 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 36: Missing | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 12: Missing | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 1 | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 52: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 44: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit | Week 20: Missing | 8 participants |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities): Level 1: I have no problems performing my usual activities; Level 2: I have some problems performing my usual activities; Level 3: I am unable to perform my usual activities.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 1 | 15 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 2 | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 1 | 14 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Missing | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 2 | 2 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 1 | 12 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Missing | 1 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 1 | 13 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 2 | 3 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 1 | 15 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 1 | 7 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Baseline: Missing | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Missing | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 1 | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Missing | 13 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 28: Missing | 8 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 4: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Missing | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 1 | 12 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 1 | 5 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 1 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 2 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 8: Missing | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 1 | 14 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 1 | 9 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 2 | 3 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 36: Missing | 11 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 12: Missing | 4 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Weeks 104-156: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 1 | 7 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 1 | 2 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 52: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Level 3 | 0 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 44: Level 2 | 1 participants |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit | Week 20: Missing | 8 participants |
Secondary
European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set; N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Baseline (N=16, 16) | 88.2 units on a scale | Standard Deviation 9.3 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 4 (N= 16, 14) | 85.6 units on a scale | Standard Deviation 13.4 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 8 (N=16, 13) | 88.4 units on a scale | Standard Deviation 11.1 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 12 (N=16, 12) | 89.9 units on a scale | Standard Deviation 12.4 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 20 (N=16, 8) | 87.1 units on a scale | Standard Deviation 14.9 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 28 (N=15, 8) | 88.0 units on a scale | Standard Deviation 10.3 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 36 (N=15, 5) | 80.5 units on a scale | Standard Deviation 22.8 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 44 (N=15, 3) | 85.9 units on a scale | Standard Deviation 12.2 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 52 (N=15, 2) | 86.2 units on a scale | Standard Deviation 13 |
| Adalimumab + MTX | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Weeks 104-156 (N=16, 15) | 85.6 units on a scale | Standard Deviation 15 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 44 (N=15, 3) | 88.7 units on a scale | Standard Deviation 9 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Baseline (N=16, 16) | 89.9 units on a scale | Standard Deviation 7.5 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 28 (N=15, 8) | 90.8 units on a scale | Standard Deviation 7.2 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 4 (N= 16, 14) | 83.2 units on a scale | Standard Deviation 19.1 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Weeks 104-156 (N=16, 15) | 86.0 units on a scale | Standard Deviation 13.7 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 8 (N=16, 13) | 82.8 units on a scale | Standard Deviation 20.7 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 36 (N=15, 5) | 90.6 units on a scale | Standard Deviation 6.3 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 12 (N=16, 12) | 82.9 units on a scale | Standard Deviation 11.6 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 52 (N=15, 2) | 89.0 units on a scale | Standard Deviation 12.7 |
| Methotrexate | European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit | Week 20 (N=16, 8) | 90.4 units on a scale | Standard Deviation 6 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit
The FACIT-Fatigue questionnaire is a self-administered patient 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.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set; N indicates the number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Baseline (N=16, 16) | 45.2 units on a scale | Standard Deviation 8.7 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 4 (N=16, 14) | 45.3 units on a scale | Standard Deviation 6.3 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 8 (N=15, 13) | 46.9 units on a scale | Standard Deviation 5.9 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 12 (N=16, 12) | 47.4 units on a scale | Standard Deviation 4.9 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 20 (N=16, 8) | 46.7 units on a scale | Standard Deviation 5.7 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 28 (N=15, 8) | 46.1 units on a scale | Standard Deviation 7.4 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 36 (N=15, 5) | 45.4 units on a scale | Standard Deviation 8.4 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 44 (N=15, 3) | 46.6 units on a scale | Standard Deviation 6.7 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 52 (N=15, 2) | 45.7 units on a scale | Standard Deviation 8.4 |
| Adalimumab + MTX | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Weeks 104-156 (N=16, 15) | 45.9 units on a scale | Standard Deviation 6.8 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 44 (N=15, 3) | 41.3 units on a scale | Standard Deviation 16.8 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Baseline (N=16, 16) | 42.5 units on a scale | Standard Deviation 5 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 28 (N=15, 8) | 42.9 units on a scale | Standard Deviation 8.9 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 4 (N=16, 14) | 43.6 units on a scale | Standard Deviation 6.3 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Weeks 104-156 (N=16, 15) | 45.3 units on a scale | Standard Deviation 6 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 8 (N=15, 13) | 44.9 units on a scale | Standard Deviation 4.8 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 36 (N=15, 5) | 43.8 units on a scale | Standard Deviation 10.1 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 12 (N=16, 12) | 41.7 units on a scale | Standard Deviation 6.9 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 52 (N=15, 2) | 37.5 units on a scale | Standard Deviation 17.7 |
| Methotrexate | Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit | Week 20 (N=16, 8) | 43.2 units on a scale | Standard Deviation 6.5 |
Secondary
Health Assessment Questionnaire (HAQ) Total Score by Visit
Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-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. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)
Population: Full analysis set; N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Baseline (N=16, 16) | 0.35 units on a scale | Standard Deviation 0.4 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 4 (N= 16, 15) | 0.35 units on a scale | Standard Deviation 0.41 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 8 (N=16, 15) | 0.34 units on a scale | Standard Deviation 0.39 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 12 (N=16, 13) | 0.31 units on a scale | Standard Deviation 0.4 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 20 (N=16, 10) | 0.37 units on a scale | Standard Deviation 0.42 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 28 (N=16, 8) | 0.36 units on a scale | Standard Deviation 0.41 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 36 (N=15, 5) | 0.37 units on a scale | Standard Deviation 0.44 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 44 (N=15, 5) | 0.38 units on a scale | Standard Deviation 0.43 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 52 (N=15, 2) | 0.44 units on a scale | Standard Deviation 0.43 |
| Adalimumab + MTX | Health Assessment Questionnaire (HAQ) Total Score by Visit | Weeks 104-156 (N=16, 15) | 0.39 units on a scale | Standard Deviation 0.47 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 44 (N=15, 5) | 0.48 units on a scale | Standard Deviation 0.29 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Baseline (N=16, 16) | 0.39 units on a scale | Standard Deviation 0.26 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 28 (N=16, 8) | 0.41 units on a scale | Standard Deviation 0.36 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 4 (N= 16, 15) | 0.42 units on a scale | Standard Deviation 0.37 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Weeks 104-156 (N=16, 15) | 0.42 units on a scale | Standard Deviation 0.33 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 8 (N=16, 15) | 0.39 units on a scale | Standard Deviation 0.31 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 36 (N=15, 5) | 0.45 units on a scale | Standard Deviation 0.27 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 12 (N=16, 13) | 0.50 units on a scale | Standard Deviation 0.37 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 52 (N=15, 2) | 0.50 units on a scale | Standard Deviation 0 |
| Methotrexate | Health Assessment Questionnaire (HAQ) Total Score by Visit | Week 20 (N=16, 10) | 0.54 units on a scale | Standard Deviation 0.41 |
Secondary
Number of Participants With a Flare
Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Population: Full analysis set; N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Number of Participants With a Flare | Week 4 (N= 16, 14) | 2 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 8 (N= 16, 13) | 0 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 12 (N= 16, 12) | 4 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 20 (N= 16, 8) | 3 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 28 (N=15, 8) | 1 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 36 (N= 15, 5) | 4 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 44 (N=15, 3) | 2 participants |
| Adalimumab + MTX | Number of Participants With a Flare | Week 52 (N= 15, 2) | 2 participants |
| Methotrexate | Number of Participants With a Flare | Week 52 (N= 15, 2) | 0 participants |
| Methotrexate | Number of Participants With a Flare | Week 4 (N= 16, 14) | 3 participants |
| Methotrexate | Number of Participants With a Flare | Week 28 (N=15, 8) | 3 participants |
| Methotrexate | Number of Participants With a Flare | Week 8 (N= 16, 13) | 3 participants |
| Methotrexate | Number of Participants With a Flare | Week 44 (N=15, 3) | 0 participants |
| Methotrexate | Number of Participants With a Flare | Week 12 (N= 16, 12) | 4 participants |
| Methotrexate | Number of Participants With a Flare | Week 36 (N= 15, 5) | 0 participants |
| Methotrexate | Number of Participants With a Flare | Week 20 (N= 16, 8) | 2 participants |
Secondary
Percentage of Participants in Remission at Week 52
Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission.
Time frame: Week 52
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab + MTX | Percentage of Participants in Remission at Week 52 | 81.3 percentage of participants |
| Methotrexate | Percentage of Participants in Remission at Week 52 | 12.5 percentage of participants |
Secondary
Percentage of Participants in Remission at Week 52 (FAS2)
Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52.
Time frame: Week 52
Population: Full analysis set 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab + MTX | Percentage of Participants in Remission at Week 52 (FAS2) | 81.3 percentage of participants |
| Methotrexate | Percentage of Participants in Remission at Week 52 (FAS2) | 13.3 percentage of participants |
Secondary
Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare
For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time frame: 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy
Population: Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare | 1 - 4 weeks after reinstitution | 66.7 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare | 5 - 8 weeks after reinstitution | 0 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare | 9 - 12 weeks after reinstitution | 22.2 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare | 13 - 16 weeks after reinstitution | 0 percentage of participants |
Secondary
Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare
For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time frame: 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy
Population: Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare | 1 - 4 weeks after reinstitution | 33.3 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare | 5 - 8 weeks after reinstitution | 0 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare | 9 - 12 weeks after reinstitution | 22.2 percentage of participants |
| Methotrexate | Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare | 13 - 16 weeks after reinstitution | 11.1 percentage of participants |
Secondary
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: No | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: No | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: Yes | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: No | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: No | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: Yes | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: No | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: No | 6 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: No | 6 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: Yes | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: No | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: Yes | 6 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: No | 6 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: Yes | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: No | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: No | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: No | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: Yes | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work | Weeks 104-156: No | 3 participants |
Secondary
Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Get Very Stiff at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: No | 7 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: No | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Get Very Stiff at Work | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: Yes | 0 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: Yes | 0 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: No | 7 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: No | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work | Weeks 104-156: No | 6 participants |
Secondary
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: No | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: No | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: No | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: No | 6 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: No | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage | Weeks 104-156: No | 5 participants |
Secondary
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: Yes | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: Yes | 0 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: No | 12 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: No | 10 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: No | 7 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Baseline: Missing | 8 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: No | 7 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 12: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis | Weeks 104-156: No | 6 participants |
Secondary
Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day | Weeks 104-156: No | 2 participants |
Secondary
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: No | 9 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: Yes | 2 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: Yes | 1 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: No | 11 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: Yes | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: No | 7 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare | Weeks 104-156: No | 6 participants |
Secondary
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind
Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: No | 7 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: Yes | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: Missing | 5 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: Missing | 3 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: Yes | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: No | 8 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: Missing | 4 participants |
| Adalimumab + MTX | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: Yes | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: Missing | 10 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: Yes | 2 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: No | 5 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Baseline: Missing | 9 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: Yes | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 12: Missing | 12 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: No | 3 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 28: Missing | 13 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: Yes | 0 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: No | 1 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Week 52: Missing | 15 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: Yes | 4 participants |
| Methotrexate | Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind | Weeks 104-156: No | 2 participants |
Secondary
Work Productivity and Activity Impairment (WPAI): Currently Employed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: Missing | 2 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: Yes | 10 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: No | 5 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: Missing | 1 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: Yes | 9 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: No | 6 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: Missing | 1 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: Yes | 10 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: No | 5 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: Missing | 1 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: Yes | 12 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: No | 3 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: Missing | 1 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: Yes | 9 participants |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: No | 5 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: Missing | 1 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: No | 5 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: Yes | 7 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: Missing | 14 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: No | 8 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: Missing | 8 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Baseline: Missing | 1 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: No | 10 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: Yes | 4 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: Yes | 1 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: No | 8 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Weeks 104-156: Yes | 5 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 12: Missing | 4 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 52: No | 1 participants |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Currently Employed | Week 28: Yes | 3 participants |
Secondary
Work Productivity and Activity Impairment (WPAI): Daily Activities
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set; N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 12 (N=15, 12) | 1.5 units on a scale | Standard Deviation 1.7 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 52 (N=15, 2) | 1.7 units on a scale | Standard Deviation 1.8 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 28 (N=15, 7) | 1.9 units on a scale | Standard Deviation 2.3 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Daily Activities | Weeks 104-156 (N=14, 15) | 2.6 units on a scale | Standard Deviation 2.3 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Daily Activities | Baseline (N=14, 15) | 1.6 units on a scale | Standard Deviation 1.8 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Daily Activities | Weeks 104-156 (N=14, 15) | 1.2 units on a scale | Standard Deviation 1 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Daily Activities | Baseline (N=14, 15) | 1.5 units on a scale | Standard Deviation 1.5 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 12 (N=15, 12) | 1.8 units on a scale | Standard Deviation 1.4 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 28 (N=15, 7) | 1.6 units on a scale | Standard Deviation 1.3 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Daily Activities | Week 52 (N=15, 2) | 1.0 units on a scale | Standard Deviation 1.4 |
Secondary
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 12 (N=7, 4) | 1.4 hours | Standard Deviation 3.8 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 52 (N=12, 1) | 1.2 hours | Standard Deviation 3 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 28 (N=10, 3) | 1.4 hours | Standard Deviation 3.3 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Weeks 104-156 (N=7, 5) | 0.0 hours | Standard Deviation 0 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Baseline (N=9, 7) | 1.1 hours | Standard Deviation 3.3 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Weeks 104-156 (N=7, 5) | 0.0 hours | Standard Deviation 0 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Baseline (N=9, 7) | 1.1 hours | Standard Deviation 3 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 12 (N=7, 4) | 0.0 hours | Standard Deviation 0 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 28 (N=10, 3) | 6.0 hours | Standard Deviation 5.3 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work | Week 52 (N=12, 1) | 0.0 hours | — |
Secondary
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 12 (N=8, 4) | 11.9 hours | Standard Deviation 16 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 52 (N=12, 1) | 6.3 hours | Standard Deviation 11.7 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 28 (N=10, 3) | 3.2 hours | Standard Deviation 5.9 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Weeks 104-156 (N=7, 5) | 2.9 hours | Standard Deviation 5.9 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Baseline (N=8, 7) | 3.8 hours | Standard Deviation 9.1 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Weeks 104-156 (N=7, 5) | 26.2 hours | Standard Deviation 56.9 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Baseline (N=8, 7) | 5.0 hours | Standard Deviation 8.9 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 12 (N=8, 4) | 8.3 hours | Standard Deviation 13.4 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 28 (N=10, 3) | 3.8 hours | Standard Deviation 4 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons | Week 52 (N=12, 1) | 16.5 hours | — |
Secondary
Work Productivity and Activity Impairment (WPAI): Hours Worked
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.
Time frame: Baseline and at Weeks 12, 28, 52 and 104-156
Population: Full analysis set participants employed or working for pay and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 12 (N=6, 3) | 29.8 hours | Standard Deviation 11.1 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 52 (N=12, 1) | 30.7 hours | Standard Deviation 11.4 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 28 (N=10, 3) | 34.7 hours | Standard Deviation 16.4 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Worked | Weeks 104-156 (N=8, 4) | 32.8 hours | Standard Deviation 12.8 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Hours Worked | Baseline (N=10, 7) | 31.5 hours | Standard Deviation 11.8 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Worked | Weeks 104-156 (N=8, 4) | 40.3 hours | Standard Deviation 16.2 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Worked | Baseline (N=10, 7) | 31.1 hours | Standard Deviation 9.7 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 12 (N=6, 3) | 38.3 hours | Standard Deviation 2.9 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 28 (N=10, 3) | 32.7 hours | Standard Deviation 9.5 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Hours Worked | Week 52 (N=12, 1) | 40.0 hours | — |
Secondary
Work Productivity and Activity Impairment (WPAI): Work Productivity
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).
Time frame: Baseline and at Weeks 12, 28, 52, and 104-156
Population: Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 12 (N=6, 3) | 1.3 units on a scale | Standard Deviation 2.4 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 52 (N=12, 1) | 1.1 units on a scale | Standard Deviation 1.8 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 28 (N=10, 3) | 1.0 units on a scale | Standard Deviation 1.5 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Work Productivity | Weeks 104-156 (N=8, 4) | 1.8 units on a scale | Standard Deviation 2.5 |
| Adalimumab + MTX | Work Productivity and Activity Impairment (WPAI): Work Productivity | Baseline (N=10, 7) | 0.8 units on a scale | Standard Deviation 1.9 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Work Productivity | Weeks 104-156 (N=8, 4) | 0.5 units on a scale | Standard Deviation 0.6 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Work Productivity | Baseline (N=10, 7) | 2.1 units on a scale | Standard Deviation 2.9 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 12 (N=6, 3) | 1.3 units on a scale | Standard Deviation 1.5 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 28 (N=10, 3) | 1.0 units on a scale | Standard Deviation 0 |
| Methotrexate | Work Productivity and Activity Impairment (WPAI): Work Productivity | Week 52 (N=12, 1) | 1.0 units on a scale | — |