Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

Study Identifier
P13-684
CT.gov Identifier
NCT01736189
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • Adalimumab
    • Phase
    N/A
    Sex
    Female & Male
    Age
    16 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions: * Disease duration of RA ≤2 years * Methotrexate (MTX) administration ≥3 months prior to starting adalimumab * Dose of MTX ≥12mg/week * Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score \>3.2
    Exclusion Criteria:
    * Participants who had been previously treated with biologics (including tumor necrosis factor \[TNF\] inhibitors and others)

    Protocol Summary

    This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.

    Study Locations

    No locations found.