Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

Study Identifier
M02-527
CT.gov Identifier
NCT00234845
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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
  • methotrexate
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history - Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria - Subject must be in paid employment - Subject has self-reported work impairment since onset of symptoms
    Exclusion Criteria:
    - A subject has chronic arthritis diagnosed before age 16 years. - Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs - Subject has preceding treatment with any biological TNF antagonist - Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study - Female subject who is pregnant or breast-feeding or considering becoming pregnant

    Protocol Summary

    The purpose of the study is to evaluate the effectiveness of adalimumab in combination with

    methotrexate compared to methotrexate alone on work disability in subjects with early

    rheumatoid arthritis

    Study Locations

    Location
    Status
    Location
    Global Medical Information - Abbott
    Abbott Park, Illinois, United States, 60064
    Status
    Not applicable