An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab; Placebo; methotrexate (MTX)
Intervention description: Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).; Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.; Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.
Intervention MeSH terms: Golimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis, Rheumatoid; Active rheumatoid arthritis; Golimumab; CNTO148; Anti-TNFalpha monoclonal antibody; Methotrexate; Intravenous

Summary:

      The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with
      methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening

          -  Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15
             mg/week for at least 3 months prior to screening, and have been on a stable MTX dose
             of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening

          -  Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender
             joints, at the time of screening and at baseline

          -  C-Reactive Protein greater than or equal to 1.0 mg/dL at screening

          -  No history of latent or active tuberculosis prior to screening

        Exclusion Criteria:

          -  Other inflammatory diseases, including but not limited to psoriatic arthritis,
             ankylosing spondylitis, systemic lupus erythematosus, or lyme disease

          -  Treated with disease modifying agents (other than methotrexate)/systemic
             immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or
             parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate
             mofetil) during the 4 weeks prior to first administration of study agent

          -  Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous
             corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to
             first administration of study agent

          -  Known allergy to human immunoglobulin proteins or other components of golimumab

          -  Received any commercial or investigational anti-tumor necrosis factor alpha therapy
             such as but not exclusively infliximab, golimumab, adalimumab or etanercept