Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

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