A Pilot Study of the Feasibility of Discontinuation of Ad... | NCT00808509

ID	Type	Description	Link
2008-004398-16	EudraCT Number

Name	Class
Pharma Consulting Group AB	INDUSTRY

Label	Type	Description	Intervention Names
Adalimumab + MTX	Active Comparator	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.	Biological: adalimumab Drug: methotrexate
Methotrexate	Experimental	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.	Drug: methotrexate

Name	Type	Description	Arm Group Labels	Other Names
adalimumab	Biological	40 mg every other week via subcutaneous injection	Adalimumab + MTX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants in Remission at Week 28	Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.	Week 28
Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)	Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.	Week 28

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants in Remission at Week 52	Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years.
Diagnosis of RA as defined by the 1987-revised American College of Rheumatology (ACR)-classification and has positive rheumatoid factor (RF) test or erosion on X-ray of hands or feet.
Currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously).
In remission as defined by disease activity score (DAS)28 <2.6 for at least the past 3 months.
Concomitant disease-modifying anti-rheumatic drug (DMARD) or oral corticosteroid therapy has been stable for at least 3 months at study entry.
Female subject is either not of childbearing potential or is practicing a relevant method of birth control.
Subject is judged to be in good general health.
Subjects must be able and willing to provide written informed consent.
Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Exclusion Criteria:

Treatment with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks.
Oral prednisone or prednisone equivalent > 10 mg/day at baseline.
Joint surgery within the preceding two months.
History of acute inflammatory joint disease other than RA.
Treatment with any investigational drug within 30 days or 5 half lives, whichever is longer prior to study entry.
Poorly controlled medical condition, which would put the subject at risk by participation in the study.
History of clinically significant hematologic, renal or liver disease.
Diagnosis of, or history suggestive of, central nervous system (CNS) demyelinating disease.
History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma of the cervix.
History of listeriosis, histoplasmosis, untreated tuberculosis (TB), persistent chronic infections, or recent active infections.
Known immune deficiency or human immunodeficiency virus (HIV).
Female who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study.

Name	Affiliation	Role
Mikael Heimburger, MD	AbbVie AB	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 22062		Linköping		581 85	Sweden
Site Reference ID/Investigator# 14022

PubMed Identifier	Type	Citation	Retractions
26819752	Derived	Chatzidionysiou K, Turesson C, Teleman A, Knight A, Lindqvist E, Larsson P, Coster L, Forslind K, van Vollenhoven R, Heimburger M. A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission. RMD Open. 2016 Jan 14;2(1):e000133. doi: 10.1136/rmdopen-2015-000133. eCollection 2016.

Label	URL
Related Info	View source

ID	Title	Description
FG000	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.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants in Remission at Week 28

Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Week 28

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00016 OG00116

Title

Denominators

Categories

Title	Measurements
	OG00087.5(61.7 to 98.4) OG00118.8(4.0 to 45.6)

Secondary

Percentage of Participants in Remission at Week 52

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.

Full analysis set

Posted

Number

95% Confidence Interval

percentage of participants

Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants in Remission at Week 52 (FAS2)

Full analysis set 2

Posted

Number

95% Confidence Interval

percentage of participants

Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With a Flare

Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

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

Posted

Number

participants

Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare

For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.

Posted

Number

95% Confidence Interval

percentage of participants

1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare

For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.

Posted

Number

95% Confidence Interval

percentage of participants

1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Health Assessment Questionnaire (HAQ) Total Score by Visit

Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit

The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:

Level 1: I have no problems in walking about;

Level 2: I have some problems in walking about;

Level 3: I am confined to bed.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit

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.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)

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.

Posted

Number

95% Confidence Interval

percentage of participants

Week 28

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit

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.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit

Level 1: I have no pain or discomfort;

Level 2: I have moderate pain or discomfort;

Level 3: I have extreme pain or discomfort.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit

Level 1: I am not anxious or depressed;

Level 2: I am moderately anxious or depressed;

Level 3: I am extremely anxious or depressed.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit

The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.

Full analysis set; N indicates the number of participants with available data.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Get Very Stiff at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do

Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Currently Employed

Full analysis set

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Hours Missed From Work

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.

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.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.

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.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Hours Worked

Full analysis set participants employed or working for pay and with available data at each time point.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Work Productivity

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).

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.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Work Productivity and Activity Impairment (WPAI): Daily Activities

The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Radiological Modified Total Sharp Score

The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

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

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 52, and Weeks 104-156

ID	Title	Description
OG000	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.
OG001	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG0031 affected16 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0011 affected7 at risk EG0021 affected9 at risk EG003
Malaise	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Nodule	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Influenza	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 affected17 at risk EG0014 affected7 at risk EG0025 affected9 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Rhinitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Shigella infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Tooth infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Upper respiratory tract	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Tooth injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Blood creatinine increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Blood thyroid stimulating hormone abnormal	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Lipids increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Rheumatoid nodule	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Migraine	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Tension headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
VIth nerve paralysis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Urge incontinence	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Oropharyngeal blistering	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0011 affected7 at risk EG0020 affected9 at risk EG003
Pustular psoriasis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0022 affected9 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	17	15	17
EG001	Methotrexate-Excluding Rescue	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.	0	7	7	7
EG002	Methotrexate-Rescue Arm	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.	3	9	8	9
EG003	Methotrexate-Including Rescue	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.	3	16	15	16

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG0031 affected16 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected17 at risk EG0010 affected7 at risk EG0020 affected9 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected17 at risk EG0010 affected7 at risk EG0021 affected9 at risk EG003