Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

Study Identifier
P13-983
CT.gov Identifier
NCT01783730
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
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. High disease activity, with poor prognostic factors (e.g., rheumatoid factor \[RF\]-positive, anti-cyclic citrullinated peptide \[CCP\] antibody-positive, or bone erosion) 2. Combination of adalimumab and methotrexate will be started 3. No prior history of treatment with disease-modifying anti-rheumatic drugs 4. No prior history of treatment with biological agents 5. Adalimumab dosed according to the registered product label 6. Signed informed consent
    Exclusion Criteria:
    There were no specific exclusion criteria.

    Protocol Summary

    This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

    Study Locations

    No locations found.