A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; Methotrexate
Intervention description: 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.; Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Anti-Inflammatory; Biological Therapy; adalimumab; Disease-Modifying Antirheumatic Drugs; Antirheumatic Agents; Agents

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised
             American College of Rheumatology-classification criteria and has disease duration of
             less than 2 years from diagnosis.

          2. Subject must have been on a dose of methotrexate therapy either subcutaneously or
             orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and
             has had an inadequate response to treatment defined as having a Disease Activity Score
             DAS28 > 3.2 (at Screening visit).

          3. Subject must also meet the following three criteria (at screening visit): at least 4
             swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed;
             subject must have an elevated erythrocyte sedimentation rate >/= 20 mm/1h or
             C-reactive protein > upper limit of normal.

          4. Subject must fulfill at least one of the following three criteria: history of
             rheumatoid factor positive; history of at least one erosion on X-ray or magnetic
             resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.

        Exclusion Criteria:

          1. Subject has previous exposure to any biologic therapy including adalimumab.

          2. Prior disease-modifying antirheumatic drugs triple therapy with methotrexate.

          3. Subject has been treated with intra-articular or parenteral administration of
             corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled
             corticosteroids for stable medical conditions are allowed.

          4. Subject has undergone joint surgery within the preceding two months (at joints to be
             assessed within the study) of Baseline.

          5. Subject has a poorly controlled medical condition, such as uncontrolled diabetes,
             unstable heart disease, congestive heart failure, recent cerebrovascular accidents and
             any other condition which, in the opinion of the Investigator, would put the subject
             at risk by participating in the study.