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:
PHASE2
Brief Summary
The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
Eligibility Criteria
Inclusion
- Participation in the prior adalimumab study
- Body weight less than 100 kg.
- Subject's who wished to continue the study drug administration
- 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.
Exclusion
- A subject who experienced any of the following during the prior adalimumab sc dosing study:
- Advanced or poorly controlled diabetes
- Any poorly controlled medical condition
- Intra-articular, intramuscular or iv administration of corticosteroids
- Joint surgery.
- A subject who has been prescribed excluded medications during previous adalimumab study.
- History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
- A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
- Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00235833
Start Date
June 1 2003
Last Update
April 11 2011
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Tokyo, Metropolis, Japan
2
Fukuoka, Prefecture, Japan
3
Hiroshima, Prefecture, Japan
4
Ibaraki, Prefecture, Japan