Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etanercept; Placebo; DMARD Therapy
Intervention description: Administered by subcutaneous injection once weekly.; Placebo subcutaneous injection; Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: RA; Enbrel; DMARD; Joint Count; Rheumatoid Arthritis; Etanercept; disease modifying anti-rheumatic drug

Summary:

      This study is designed to evaluate the effectiveness of adding etanercept to disease
      modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid
      Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 and ≤80 years of age at time of screening

          -  Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of
             Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at
             least 6 months

          -  Moderate rheumatoid arthritis during screening, as defined by a disease activity score
             (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2 and ≤ 5.1

          -  Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined)
             and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline.
             (A full 66/68 count joint count will be performed at baseline, but only joints in the
             28-count joint count will be considered for eligibility. The 28-joint count consists
             of the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
             shoulders, and knees)

          -  Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide,
             minocycline, and/or hydroxychloroquine

        Exclusion Criteria:

          -  Prosthetic joint infection within 5 years of screening or native joint infection
             within 1 year of screening

          -  Class IV rheumatoid arthritis according to ACR revised response criteria

          -  Any active infection (including chronic or localized infections) for which
             anti-infectives were indicated within 28 days prior to first investigational product
             dose

          -  Previously used more than one experimental biologic DMARD. Patient with prior use of
             no more than one experimental biologic is permitted if the subject received no more
             than 8 weeks of treatment. The use of the experimental biologic must not have occurred
             within 2 months of the first dose of investigational product

          -  Previously used more than one commercially available biologic DMARD. Subject with
             prior use of no more than one commercially available biologic is permitted if the
             patient received no more than 8 weeks of treatment and did not discontinue because of
             lack of effect. The use of the biologic must not have occurred within 2 months of the
             first dose of investigational product. Acceptable prior use of biologics include the
             following examples:

          -  No more than 4 injections of adalimumab

          -  No more than 8 (50 mg) injections of etanercept

          -  No more than 2 infusions of infliximab

          -  No more than 2 infusions of abatacept

          -  Additional inclusion (exclusion) criteria may apply