Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Study Identifier
M02-532
CT.gov Identifier
NCT00650390
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Other
Sign up for trial alerts

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • adalimumab
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Males and females >= 18 years of age - ACR criteria for RA diagnosis for at least 6 months - Active RA defined as a DAS 28 >3.2 at study entry - Unsatisfactory response, loss of response or intolerance to prior infliximab treatment - A negative pregnancy test for females of childbearing potential
    Exclusion Criteria:
    - Patient who had previous treatment with cyclophosphamide and chlorambucil - Treatment within the last 8 weeks with infliximab - Prior treatment with more than one DMARD or DMARD combination following infliximab treatment - Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab - History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease - Prior treatment with total lymphoid irradiation

    Protocol Summary

    The study was to explore the efficacy of adalimumab in subjects previously treated with

    infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore

    the safety of adalimumab in subjects previously treated with infliximab.

    Study Locations

    No locations found.