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

Sponsor
Abbott (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00650390
Collaborator
(none)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: adalimumab

Study Design

Study Type:
Expanded Access
Official Title:
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Abbott

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00650390
    Other Study ID Numbers:
    • M02-532
    First Posted:
    Apr 1, 2008
    Last Update Posted:
    Apr 1, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Adalimumab

    Study Results

    No Results Posted as of Apr 1, 2008