A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Study Identifier
M02-575
CT.gov Identifier
NCT00647491
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
  • placebo
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints. - Subjects must have failed prior treatment with one or more DMARDs. - A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration. - Body weight less than or equal to 100 kg
    Exclusion Criteria:
    - A history of, or current, acute inflammatory joint disease of different origin from RA. - Prior treatment with any TNF antagonist, including adalimumab. - Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics. - Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

    Protocol Summary

    The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics

    of three doses of adalimumab in adult Japanese subjects with RA

    Study Locations

    Location
    Status
    Location
    Aichi, Japan
    Status
    Not applicable
    Location
    Chiba, Japan
    Status
    Not applicable
    Location
    Ehime, Japan
    Status
    Not applicable
    Location
    Fukui, Japan
    Status
    Not applicable
    Location
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Gunma, Japan
    Status
    Not applicable
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