Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Study Identifier
M03-651
CT.gov Identifier
NCT00235872
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Tokyo, Metropolis, Japan
    Status
    Not applicable
    Location
    Aichi, Prefecture, Japan
    Status
    Not applicable
    Location
    Chiba, Prefecture, Japan
    Status
    Not applicable
    Location
    Ehime, Prefecture, Japan
    Status
    Not applicable
    Location
    Fukui, Prefecture, Japan
    Status
    Not applicable
    Location
    Fukuoka, Prefecture, Japan
    Status
    Not applicable
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