A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Study Identifier
M14-500
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Immune & Inflammatory - Other
  • Study Drug
  • Adalimumab
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

    Study Locations

    Location
    Status
    Location
    J Michael Grelier Research /ID# 149772
    Tuscaloosa, Alabama, United States, 35406
    Status
    Not applicable
    Location
    Westlake Medical Research (WMR) Clinical Trials /ID# 155386
    Thousand Oaks, California, United States, 91360-3994
    Status
    Not applicable
    Location
    University of Florida /ID# 144851
    Jacksonville, Florida, United States, 32209
    Status
    Not applicable
    Location
    North Georgia Rheumatology Grp /ID# 155225
    Lawrenceville, Georgia, United States, 30045
    Status
    Not applicable
    Location
    The Arthritis & Diabetes Clinic, Inc. /ID# 149017
    Monroe, Louisiana, United States, 71203
    Status
    Not applicable
    Location
    Aa Mrc Llc /Id# 151933
    Grand Blanc, Michigan, United States, 48439
    Status
    Not applicable
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