Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; placebo
Intervention description: etanercept 50mg once weekly + methotrexate with or without other DMARDs; etanercept placebo once weekly + methotrexate with or without other DMARDs
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; etanercept; methotrexate; DMARDs

Summary:

      To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly
      plus methotrexate with or without other disease modifying antirheumatic drugs therapy with
      that of methotrexate with or without other disease modifying antirheumatic drugs therapy at
      Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved
      low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly
      plus MTX with or without other disease modifying antirheumatic drugs therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the
             1987 American College of Rheumatology (ACR) Revised criteria for RA.

          2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of
             ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks
             immediately prior to screening.

        Exclusion Criteria:

          1. Subjects who used any of the following systemic treatments during the washout periods
             given below:

               1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in
                  dose within 28 days of baseline.

               2. Treatment with more than 1 NSAID within 14 days at baseline.

               3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate
                  within 28 days of baseline.

               4. Subjects will be allowed to continue the following non biologic DMARDs:
                  sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs
                  (including but not limited to gold, penicillamine, azathioprine,
                  cyclophospamide), and biologic DMARDs must have been discontinued at least 2
                  months prior to Week 1.

               5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.

          2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

          3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.