A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Study Identifier
M06-859
CT.gov Identifier
NCT00870467
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
  • Double-blind adalimumab
  • Double-blind Placebo
  • Open-label Adalimumab
  • Open-labelAdalimumabRescue
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria - Rheumatoid arthritis based on the American College of Rheumatology criteria - Methotrexate or leflunomide naïve - Disease duration less than or equal to 2 years from diagnosis Exclusion Criteria - History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV - Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus - Joint surgery involving joints to be assessed within 8 weeks prior to Screening

    Protocol Summary

    To evaluate the potential of adalimumab to inhibit radiographic progression in joint

    destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid

    arthritis.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 46861
    Anjo, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46919
    Aomori, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46805
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46806
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46880
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46881
    Chiba, Japan
    Status
    Not applicable
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