Status:
COMPLETED
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00235872
Start Date
August 1 2004
Last Update
April 11 2011
Active Locations (25)
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1
Tokyo, Metropolis, Japan
2
Aichi, Prefecture, Japan
3
Chiba, Prefecture, Japan
4
Ehime, Prefecture, Japan