Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

• 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) ] [ Designated as safety issue: No ]
  Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
• 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) ] [ Designated as safety issue: No ]
  Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.
• 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). ] [ Designated as safety issue: No ]
  Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
• 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). ] [ Designated as safety issue: No ]
  Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
• 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). ] [ Designated as safety issue: No ]
  Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
• 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) ] [ Designated as safety issue: No ]
  Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions
• 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) ] [ Designated as safety issue: No ]
  Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
• 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) ] [ Designated as safety issue: No ]
  The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
• 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) ] [ Designated as safety issue: No ]
  Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
• 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) ] [ Designated as safety issue: No ]
  The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.
• 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) ] [ Designated as safety issue: No ]
  Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

• ACR 20/50/70
• Patient Reported outcomes
• Physician Global Assessment

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.

Inclusion Criteria:

• Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
• Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
• Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.

Exclusion Criteria:

• A subject who experienced any of the following during prior study:

  • Advanced or poorly controlled diabetes
  • Joint surgery (joint evaluated in this study)
• A subject who has been prescribed excluded medications during prior study.

• History of following during prior study:

  • Clinically significant drug or alcohol abuse
  • Intravenous (iv) drug abuse
  • Active infection with listeria or tuberculosis (TB)
  • Lymphoma, leukemia
  • And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
• A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

• Abbott Japan Co.,Ltd
• Eisai Co., Ltd.