Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Abbott

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235872

M03-651

Details and patient eligibility

About

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.

Enrollment

309 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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