A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01162421
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.
  • Methotrexate — DRUG
    Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Study Details

A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Key Dates

Start date
Sep 30, 2010
Status verified
Sep 2016
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Adalimumab
    Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.
  • Active Comparator: Standard of Care
    Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.

Primary Outcome Measure

Percentage of Participants With No Radiographic Progression at Month 12 [ Time Frame: Baseline, Month 12 ]

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