Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Study Identifier
M10-261
CT.gov Identifier
NCT00647270
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
Download document(s)

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • adalimumab
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject > 18 years of age - Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months - Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed - If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment - Subject is judged to be in generally good health as determined by the principal investigator
    Exclusion Criteria:
    - Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab - Subject has a history of acute inflammatory joint disease of different origin other than RA - Subject has been treated with any investigational biologic agents - 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

    To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and

    demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of

    40 mg adalimumab every other week.

    Study Locations

    Location
    Status
    Location
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Tuscaloosa, Alabama, United States, 35406
    Status
    Not applicable
    Location
    Paradise Valley, Arizona, United States, 85253
    Status
    Not applicable
    Location
    Hemet, California, United States, 92543
    Status
    Not applicable
    Location
    Long Beach, California, United States, 90806
    Status
    Not applicable
    Location
    Santa Monica, California, United States, 90404
    Status
    Not applicable
    Showing {first} - {last} of {total} Results