Trial Outcomes & Findings for A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (NCT NCT00808509)

NCT ID: NCT00808509

Last Updated: 2013-12-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Week 28
• Results posted on: 2013-12-16

Participant Flow

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.

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).

Participant milestones

Measure	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.	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.
Randomized Phase STARTED	17	16
Randomized Phase Received Rescue Therapy	0	9
Randomized Phase COMPLETED	15	11
Randomized Phase NOT COMPLETED	2	5
Observation Phase STARTED	16	15
Observation Phase COMPLETED	16	15
Observation Phase NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.	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.
Randomized Phase Did not meet eligibility criteria	1	0
Randomized Phase Reduced methotrexate dose	1	2
Randomized Phase Patient refused rescue therapy	0	3

Baseline Characteristics

A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission

Baseline characteristics by cohort

Measure	Adalimumab + MTX n=17 Participants 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.	Methotrexate n=16 Participants 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.	Total n=33 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 13.0 • n=5 Participants	61.3 years STANDARD_DEVIATION 9.9 • n=7 Participants	56.8 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Sweden	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Disease duration	10.4 years STANDARD_DEVIATION 8.9 • n=5 Participants	13.2 years STANDARD_DEVIATION 12.5 • n=7 Participants	11.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Disease Activity Score (DAS) 28	1.98 units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	1.73 units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	1.86 units on a scale STANDARD_DEVIATION 0.55 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Percentage of Participants in Remission at Week 28	87.5 percentage of participants Interval 61.7 to 98.4	18.8 percentage of participants Interval 4.0 to 45.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=15 Participants 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.
Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)	87.5 percentage of participants Interval 61.7 to 98.4	20.0 percentage of participants Interval 4.3 to 48.1

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Percentage of Participants in Remission at Week 52	81.3 percentage of participants Interval 54.4 to 96.0	12.5 percentage of participants Interval 1.6 to 38.3

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set 2

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=15 Participants 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.
Percentage of Participants in Remission at Week 52 (FAS2)	81.3 percentage of participants Interval 54.4 to 96.0	13.3 percentage of participants Interval 1.7 to 40.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Number of Participants With a Flare Week 4 (N= 16, 14)	2 participants	3 participants
Number of Participants With a Flare Week 8 (N= 16, 13)	0 participants	3 participants
Number of Participants With a Flare Week 12 (N= 16, 12)	4 participants	4 participants
Number of Participants With a Flare Week 20 (N= 16, 8)	3 participants	2 participants
Number of Participants With a Flare Week 28 (N=15, 8)	1 participants	3 participants
Number of Participants With a Flare Week 36 (N= 15, 5)	4 participants	0 participants
Number of Participants With a Flare Week 44 (N=15, 3)	2 participants	0 participants
Number of Participants With a Flare Week 52 (N= 15, 2)	2 participants	0 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	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.	Methotrexate n=9 Participants 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.
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 Interval 7.5 to 70.1
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 Interval 0.0 to 33.6
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 Interval 2.8 to 60.0
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 Interval 0.3 to 48.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	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.	Methotrexate n=9 Participants 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.
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 Interval 29.9 to 92.5
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 Interval 0.0 to 33.6
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 Interval 2.8 to 60.0
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 Interval 0.0 to 33.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Health Assessment Questionnaire (HAQ) Total Score by Visit Weeks 104-156 (N=16, 15)	0.39 units on a scale Standard Deviation 0.47	0.42 units on a scale Standard Deviation 0.33
Health Assessment Questionnaire (HAQ) Total Score by Visit Baseline (N=16, 16)	0.35 units on a scale Standard Deviation 0.40	0.39 units on a scale Standard Deviation 0.26
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 4 (N= 16, 15)	0.35 units on a scale Standard Deviation 0.41	0.42 units on a scale Standard Deviation 0.37
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 8 (N=16, 15)	0.34 units on a scale Standard Deviation 0.39	0.39 units on a scale Standard Deviation 0.31
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 12 (N=16, 13)	0.31 units on a scale Standard Deviation 0.40	0.50 units on a scale Standard Deviation 0.37
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 20 (N=16, 10)	0.37 units on a scale Standard Deviation 0.42	0.54 units on a scale Standard Deviation 0.41
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 28 (N=16, 8)	0.36 units on a scale Standard Deviation 0.41	0.41 units on a scale Standard Deviation 0.36
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 36 (N=15, 5)	0.37 units on a scale Standard Deviation 0.44	0.45 units on a scale Standard Deviation 0.27
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 44 (N=15, 5)	0.38 units on a scale Standard Deviation 0.43	0.48 units on a scale Standard Deviation 0.29
Health Assessment Questionnaire (HAQ) Total Score by Visit Week 52 (N=15, 2)	0.44 units on a scale Standard Deviation 0.43	0.50 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Baseline: Level 1	12 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Baseline: Level 2	4 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Baseline: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Baseline: Missing	0 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 4: Level 1	13 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 4: Level 2	3 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 4: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 4: Missing	0 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 8: Level 1	11 participants	10 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 8: Level 2	5 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 8: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 8: Missing	0 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 12: Level 1	13 participants	10 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 12: Level 2	3 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 12: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 12: Missing	0 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 20: Level 1	12 participants	6 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 20: Level 2	4 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 20: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 20: Missing	0 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 28: Level 1	10 participants	7 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 28: Level 2	5 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 28: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 28: Missing	1 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 36: Level 1	10 participants	5 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 36: Level 2	5 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 36: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 36: Missing	1 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 44: Level 1	11 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 44: Level 2	4 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 44: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 44: Missing	1 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 52: Level 1	10 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 52: Level 2	5 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 52: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Week 52: Missing	1 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Weeks 104-156: Level 1	10 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Weeks 104-156: Level 2	6 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Weeks 104-156: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit Weeks 104-156: Missing	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Baseline: Level 1	15 participants	16 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Baseline: Level 2	1 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Baseline: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Baseline: Missing	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 4: Level 1	16 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 4: Level 2	0 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 4: Level 3	0 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 4: Missing	0 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 8: Level 1	16 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 8: Level 2	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 8: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 8: Missing	0 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 12: Level 1	15 participants	9 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 12: Level 2	1 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 12: Level 3	0 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 12: Missing	0 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 20: Level 1	16 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 20: Level 2	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 20: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 20: Missing	0 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 28: Level 1	14 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 28: Level 2	1 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 28: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 28: Missing	1 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 36: Level 1	15 participants	5 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 36: Level 2	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 36: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 36: Missing	1 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 44: Level 1	14 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 44: Level 2	1 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 44: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 44: Missing	1 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 52: Level 1	15 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 52: Level 2	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 52: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Week 52: Missing	1 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Weeks 104-156: Level 1	16 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Weeks 104-156: Level 2	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Weeks 104-156: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit Weeks 104-156: Missing	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Baseline: Level 1	14 participants	15 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Baseline: Level 2	2 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Baseline: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Baseline: Missing	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 4: Level 1	14 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 4: Level 2	2 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 4: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 4: Missing	0 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 8: Level 1	15 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 8: Level 2	1 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 8: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 8: Missing	0 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 12: Level 1	14 participants	9 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 12: Level 2	2 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 12: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 12: Missing	0 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 20: Level 1	13 participants	7 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 20: Level 2	3 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 20: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 20: Missing	0 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 28: Level 1	13 participants	7 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 28: Level 2	2 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 28: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 28: Missing	1 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 36: Level 1	12 participants	5 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 36: Level 2	3 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 36: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 36: Missing	1 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 44: Level 1	12 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 44: Level 2	3 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 44: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 44: Missing	1 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 52: Level 1	12 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 52: Level 2	3 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 52: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Week 52: Missing	1 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Weeks 104-156: Level 1	13 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Weeks 104-156: Level 2	3 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Weeks 104-156: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit Weeks 104-156: Missing	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 8: Missing	0 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Baseline: Level 1	6 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Baseline: Level 2	10 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Baseline: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Baseline: Missing	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 4: Level 1	8 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 4: Level 2	8 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 4: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 4: Missing	0 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 8: Level 1	7 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 12: Level 1	8 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 8: Level 2	9 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 8: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 12: Level 2	8 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 12: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 12: Missing	0 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 20: Level 1	7 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 20: Level 2	9 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 20: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 20: Missing	0 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 28: Level 1	5 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 28: Level 2	10 participants	5 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 28: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 28: Missing	1 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 36: Level 1	8 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 36: Level 2	7 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 36: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 36: Missing	1 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 44: Level 1	7 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 44: Level 2	8 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 44: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 44: Missing	1 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 52: Level 1	5 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 52: Level 2	10 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 52: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Week 52: Missing	1 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Weeks 104-156: Level 1	8 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Weeks 104-156: Level 2	8 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Weeks 104-156: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit Weeks 104-156: Missing	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Baseline: Level 1	14 participants	12 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Baseline: Level 2	2 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Baseline: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Baseline: Missing	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 4: Level 1	13 participants	10 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 4: Level 2	3 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 4: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 4: Missing	0 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 8: Level 1	13 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 8: Level 2	3 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 8: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 8: Missing	0 participants	3 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 12: Level 1	14 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 12: Level 2	2 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 12: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 12: Missing	0 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 20: Level 1	13 participants	6 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 20: Level 2	3 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 20: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 20: Missing	0 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 28: Level 1	13 participants	6 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 28: Level 2	2 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 28: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 28: Missing	1 participants	8 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 36: Level 1	12 participants	4 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 36: Level 2	3 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 36: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 36: Missing	1 participants	11 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 44: Level 1	13 participants	2 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 44: Level 2	2 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 44: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 44: Missing	1 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 52: Level 1	11 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 52: Level 2	4 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 52: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Week 52: Missing	1 participants	14 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Weeks 104-156: Level 1	11 participants	13 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Weeks 104-156: Level 2	5 participants	1 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Weeks 104-156: Level 3	0 participants	0 participants
European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit Weeks 104-156: Missing	0 participants	2 participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	89.9 units on a scale Standard Deviation 7.5
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	83.2 units on a scale Standard Deviation 19.1
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	82.8 units on a scale Standard Deviation 20.7
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	82.9 units on a scale Standard Deviation 11.6
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	90.4 units on a scale Standard Deviation 6.0
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	90.8 units on a scale Standard Deviation 7.2
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	90.6 units on a scale Standard Deviation 6.3
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	88.7 units on a scale Standard Deviation 9.0
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 13.0	89.0 units on a scale Standard Deviation 12.7
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 15.0	86.0 units on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	41.7 units on a scale Standard Deviation 6.9
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	43.2 units on a scale Standard Deviation 6.5
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	42.5 units on a scale Standard Deviation 5.0
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	43.6 units on a scale Standard Deviation 6.3
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	44.9 units on a scale Standard Deviation 4.8
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	42.9 units on a scale Standard Deviation 8.9
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	43.8 units on a scale Standard Deviation 10.1
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	41.3 units on a scale Standard Deviation 16.8
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	37.5 units on a scale Standard Deviation 17.7
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	45.3 units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Baseline: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Baseline: No	10 participants	7 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Baseline: Missing	4 participants	8 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 12: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 12: No	10 participants	7 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 12: Missing	5 participants	9 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 28: Yes	2 participants	0 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 28: No	10 participants	3 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 52: Yes	3 participants	0 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 52: No	10 participants	1 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Weeks 104-156: Yes	0 participants	0 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Weeks 104-156: No	12 participants	6 participants
Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Baseline: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Baseline: No	11 participants	7 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 12: Yes	1 participants	1 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 12: No	10 participants	3 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 28: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 28: No	11 participants	3 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 52: Yes	1 participants	1 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 52: No	12 participants	0 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Weeks 104-156: Yes	1 participants	1 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Weeks 104-156: No	11 participants	5 participants
Work Instability Score (WIS) for RA: I Get Very Stiff at Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Baseline: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Baseline: No	10 participants	6 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 12: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 12: No	9 participants	3 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 28: Yes	2 participants	2 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 28: No	10 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 52: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 52: No	11 participants	0 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Weeks 104-156: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Weeks 104-156: No	9 participants	5 participants
Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Baseline: Yes	3 participants	0 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Baseline: No	9 participants	7 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 12: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 12: No	9 participants	3 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 28: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 28: No	11 participants	3 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 52: Yes	2 participants	0 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 52: No	11 participants	1 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Weeks 104-156: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Weeks 104-156: No	11 participants	6 participants
Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Baseline: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Weeks 104-156: No	10 participants	5 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Baseline: No	10 participants	6 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 12: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 12: No	9 participants	3 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 28: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 28: No	9 participants	2 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 52: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 52: No	10 participants	0 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Weeks 104-156: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Baseline: Yes	6 participants	4 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Baseline: No	6 participants	3 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 12: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 12: No	6 participants	2 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 28: Yes	6 participants	1 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 28: No	6 participants	2 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 52: Yes	9 participants	1 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 52: No	4 participants	0 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Weeks 104-156: Yes	5 participants	3 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Weeks 104-156: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Baseline: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Baseline: No	9 participants	6 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 28: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 28: No	10 participants	2 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 52: Yes	3 participants	0 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 52: No	10 participants	1 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Weeks 104-156: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Weeks 104-156: No	9 participants	5 participants
Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	1 participants
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	3 participants
Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work Baseline: Yes	3 participants	1 participants
Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work Baseline: No	9 participants	6 participants
Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work Baseline: Missing	4 participants	9 participants
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	12 participants
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	0 participants
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	3 participants
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	13 participants
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	0 participants
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	1 participants
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	15 participants
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	1 participants
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	5 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Baseline: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Baseline: No	10 participants	6 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 12: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 12: No	9 participants	3 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 28: Yes	3 participants	0 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 28: No	9 participants	3 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 52: Yes	1 participants	1 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 52: No	12 participants	0 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Weeks 104-156: Yes	2 participants	1 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Weeks 104-156: No	10 participants	5 participants
Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Baseline: Yes	0 participants	0 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Baseline: No	12 participants	7 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 12: Yes	0 participants	0 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 12: No	11 participants	4 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 28: Yes	0 participants	0 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 28: No	12 participants	3 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 52: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 52: No	12 participants	1 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Weeks 104-156: Yes	1 participants	0 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Weeks 104-156: No	11 participants	6 participants
Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	2 participants
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	5 participants
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	9 participants
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	1 participants
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	3 participants
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	12 participants
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	0 participants
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	3 participants
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	13 participants
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	0 participants
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	1 participants
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	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	5 participants
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	9 participants
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	2 participants
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	1 participants
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	3 participants
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	12 participants
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	0 participants
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	3 participants
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	13 participants
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	0 participants
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	1 participants
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	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work Week 52: Missing	3 participants	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work Week 52: Missing	3 participants	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	1 participants
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	12 participants
Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain Baseline: Missing	4 participants	9 participants
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	3 participants
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	0 participants
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	3 participants
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	13 participants
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	0 participants
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	1 participants
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	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Baseline: Missing	4 participants	9 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 12: Yes	4 participants	1 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 12: No	7 participants	3 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 12: Missing	5 participants	12 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 28: Yes	4 participants	0 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 28: No	8 participants	3 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 28: Missing	4 participants	13 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 52: Yes	5 participants	0 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 52: No	8 participants	1 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Week 52: Missing	3 participants	15 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Weeks 104-156: Yes	4 participants	4 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Weeks 104-156: No	8 participants	2 participants
Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind Weeks 104-156: Missing	4 participants	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do Baseline: Yes	5 participants	2 participants
Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do Baseline: No	7 participants	5 participants
Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do Baseline: Missing	4 participants	9 participants
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	1 participants
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	3 participants
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	12 participants
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	0 participants
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	3 participants
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	13 participants
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	0 participants
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	1 participants
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	15 participants
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	4 participants
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	2 participants
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	10 participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 12, 28, 52, and 104-156

Population: Full analysis set

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).

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Currently Employed Baseline: Yes	10 participants	7 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Baseline: No	5 participants	8 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Baseline: Missing	1 participants	1 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 12: Yes	9 participants	4 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 12: No	6 participants	8 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 12: Missing	1 participants	4 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 28: Yes	10 participants	3 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 28: No	5 participants	5 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 28: Missing	1 participants	8 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 52: Yes	12 participants	1 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 52: No	3 participants	1 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Week 52: Missing	1 participants	14 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Weeks 104-156: Yes	9 participants	5 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Weeks 104-156: No	5 participants	10 participants
Work Productivity and Activity Impairment (WPAI): Currently Employed Weeks 104-156: Missing	2 participants	1 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work Baseline (N=9, 7)	1.1 hours Standard Deviation 3.3	1.1 hours Standard Deviation 3.0
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work Week 12 (N=7, 4)	1.4 hours Standard Deviation 3.8	0.0 hours Standard Deviation 0.0
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work Week 28 (N=10, 3)	1.4 hours Standard Deviation 3.3	6.0 hours Standard Deviation 5.3
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work Week 52 (N=12, 1)	1.2 hours Standard Deviation 3.0	0.0 hours Standard Deviation NA Cannot be calculated due to sample size=1.
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work Weeks 104-156 (N=7, 5)	0.0 hours Standard Deviation 0.0	0.0 hours Standard Deviation 0.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons Baseline (N=8, 7)	3.8 hours Standard Deviation 9.1	5.0 hours Standard Deviation 8.9
Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons Week 12 (N=8, 4)	11.9 hours Standard Deviation 16.0	8.3 hours Standard Deviation 13.4
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	3.8 hours Standard Deviation 4.0
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	16.5 hours Standard Deviation NA Cannot be calculated due to a sample size of 1.
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	26.2 hours Standard Deviation 56.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Hours Worked Baseline (N=10, 7)	31.5 hours Standard Deviation 11.8	31.1 hours Standard Deviation 9.7
Work Productivity and Activity Impairment (WPAI): Hours Worked Week 12 (N=6, 3)	29.8 hours Standard Deviation 11.1	38.3 hours Standard Deviation 2.9
Work Productivity and Activity Impairment (WPAI): Hours Worked Week 28 (N=10, 3)	34.7 hours Standard Deviation 16.4	32.7 hours Standard Deviation 9.5
Work Productivity and Activity Impairment (WPAI): Hours Worked Week 52 (N=12, 1)	30.7 hours Standard Deviation 11.4	40.0 hours Standard Deviation NA Cannot be calculated due to a sample size of 1.
Work Productivity and Activity Impairment (WPAI): Hours Worked Weeks 104-156 (N=8, 4)	32.8 hours Standard Deviation 12.8	40.3 hours Standard Deviation 16.2

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Work Productivity Baseline (N=10, 7)	0.8 units on a scale Standard Deviation 1.9	2.1 units on a scale Standard Deviation 2.9
Work Productivity and Activity Impairment (WPAI): Work Productivity Week 12 (N=6, 3)	1.3 units on a scale Standard Deviation 2.4	1.3 units on a scale Standard Deviation 1.5
Work Productivity and Activity Impairment (WPAI): Work Productivity Week 28 (N=10, 3)	1.0 units on a scale Standard Deviation 1.5	1.0 units on a scale Standard Deviation 0.0
Work Productivity and Activity Impairment (WPAI): Work Productivity Week 52 (N=12, 1)	1.1 units on a scale Standard Deviation 1.8	1.0 units on a scale Standard Deviation NA Could not be calculated due to a sample size of 1.
Work Productivity and Activity Impairment (WPAI): Work Productivity Weeks 104-156 (N=8, 4)	1.8 units on a scale Standard Deviation 2.5	0.5 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
Work Productivity and Activity Impairment (WPAI): Daily Activities Baseline (N=14, 15)	1.6 units on a scale Standard Deviation 1.8	1.5 units on a scale Standard Deviation 1.5
Work Productivity and Activity Impairment (WPAI): Daily Activities Week 12 (N=15, 12)	1.5 units on a scale Standard Deviation 1.7	1.8 units on a scale Standard Deviation 1.4
Work Productivity and Activity Impairment (WPAI): Daily Activities Week 28 (N=15, 7)	1.9 units on a scale Standard Deviation 2.3	1.6 units on a scale Standard Deviation 1.3
Work Productivity and Activity Impairment (WPAI): Daily Activities Week 52 (N=15, 2)	1.7 units on a scale Standard Deviation 1.8	1.0 units on a scale Standard Deviation 1.4
Work Productivity and Activity Impairment (WPAI): Daily Activities Weeks 104-156 (N=14, 15)	2.6 units on a scale Standard Deviation 2.3	1.2 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, Week 52, and Weeks 104-156

Population: Full analysis set; N indicates the number of participants with available data at each time point.

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.

Outcome measures

Measure	Adalimumab + MTX n=16 Participants 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.	Methotrexate n=16 Participants 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.
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	-0.8 units on a scale Standard Deviation 13.5
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	-7.2 units on a scale Standard Deviation 15.7

Adverse Events

Adalimumab + MTX

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Methotrexate-Excluding Rescue

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Methotrexate-Rescue Arm

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Methotrexate-Including Rescue

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab + MTX n=17 participants at risk 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.	Methotrexate-Excluding Rescue n=7 participants at risk Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.	Methotrexate-Rescue Arm n=9 participants at risk Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.	Methotrexate-Including Rescue n=16 participants at risk Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone 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.
General disorders Chest pain	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Femur fracture	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).

Other adverse events

Measure	Adalimumab + MTX n=17 participants at risk 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.	Methotrexate-Excluding Rescue n=7 participants at risk Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.	Methotrexate-Rescue Arm n=9 participants at risk Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.	Methotrexate-Including Rescue n=16 participants at risk Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Blood and lymphatic system disorders Lymph node pain	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Blood and lymphatic system disorders Neutropenia	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Gastrointestinal disorders Colonic polyp	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Gastrointestinal disorders Gastritis	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Gastrointestinal disorders Nausea	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Gastrointestinal disorders Toothache	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
General disorders Fatigue	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	12.5% 2/16 • From randomization through the observational extension visit (up to Week 156).
General disorders Malaise	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
General disorders Nodule	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
General disorders Pain	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Gastroenteritis	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Herpes zoster	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Infection	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Influenza	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Nasopharyngitis	29.4% 5/17 • From randomization through the observational extension visit (up to Week 156).	57.1% 4/7 • From randomization through the observational extension visit (up to Week 156).	55.6% 5/9 • From randomization through the observational extension visit (up to Week 156).	56.2% 9/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Pneumonia	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Pyelonephritis	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Rhinitis	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Shigella infection	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Sinusitis	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Tooth infection	11.8% 2/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Upper respiratory tract	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Infections and infestations Urinary tract infection	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Contusion	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Foot fracture	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Hand fracture	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Humerus fracture	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Joint sprain	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Limb injury	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Tooth injury	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Injury, poisoning and procedural complications Wound	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Investigations Blood creatinine increased	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Investigations Blood thyroid stimulating hormone abnormal	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Investigations Lipids increased	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 2/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Musculoskeletal and connective tissue disorders Coccydynia	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Musculoskeletal and connective tissue disorders Pain in extremity	11.8% 2/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Musculoskeletal and connective tissue disorders Rheumatoid nodule	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders Dementia Alzheimer's type	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders Headache	11.8% 2/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders Hypoaesthesia	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders Migraine	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders Tension headache	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Nervous system disorders VIth nerve paralysis	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Renal and urinary disorders Urge incontinence	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Respiratory, thoracic and mediastinal disorders Throat irritation	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Blister	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Eczema	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Erythema	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	14.3% 1/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Rash	17.6% 3/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Rash erythematous	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Rosacea	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Skin and subcutaneous tissue disorders Urticaria	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/9 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/16 • From randomization through the observational extension visit (up to Week 156).
Vascular disorders Hypertension	0.00% 0/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	22.2% 2/9 • From randomization through the observational extension visit (up to Week 156).	12.5% 2/16 • From randomization through the observational extension visit (up to Week 156).
Vascular disorders Peripheral coldness	5.9% 1/17 • From randomization through the observational extension visit (up to Week 156).	0.00% 0/7 • From randomization through the observational extension visit (up to Week 156).	11.1% 1/9 • From randomization through the observational extension visit (up to Week 156).	6.2% 1/16 • From randomization through the observational extension visit (up to Week 156).

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER