Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Adalimumab 40 mg Eow	Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Participant Flow:   Overall Study

	Adalimumab 40 mg Eow
STARTED	309
COMPLETED	162
NOT COMPLETED	147
Adverse Event	34
Death	1
Lost to Follow-up	1
Withdrawal by Subject	50
Administrative reason	61

Reporting Groups

	Description
Adalimumab 40 mg Eow	Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Baseline Measures

	Adalimumab 40 mg Eow
Number of Participants   [units: participants]	309
Age, Customized   [units: participants]
< 40 years	35
Between 40 and 49 years	57
Between 50 and 59 years	111
>/= 60 years	106
Gender   [units: participants]
Female	249
Male	60
Region of Enrollment   [units: participants]
Japan	309

1.  Primary:

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

2.  Secondary:

Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

3.  Secondary:

Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

4.  Secondary:

Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]

5.  Secondary:

Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]

6.  Secondary:

Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]

7.  Secondary:

Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

8.  Secondary:

Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

9.  Secondary:

Presence of Morning Stiffness   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

10.  Secondary:

Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

11.  Secondary:

Presence of Rheumatoid Factor (RF)   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

12.  Secondary:

Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]