An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab 100 mg; Golimumab 50 mg; Methotrexate; Placebo injection; Placebo capsules
Intervention description: Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.; Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.; Participants will receive methotrexate capsules weekly.; Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.; Participants will receive placebo capsules weekly
Intervention MeSH terms: Golimumab; Methotrexate; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Golimumab; Methotrexate; Fully Human anti-TNFa monoclonal antibody; Simpony

Summary:

      The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in
      combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid
      arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria
             of the ACR) for at least 3 months prior to screening

          -  Must 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 a MTX dose of >=15 mg/week
             and <=25 mg/week and stable for at least 4 weeks prior to screening

          -  Have active RA as defined by persistent disease activity with at least 4 swollen and 4
             tender joints, at the time of screening and baseline, and at least 2 of the following
             4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte
             sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at
             screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline,
             c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first
             administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP)
             antibody-positive or rheumatoid factor (RF) positive at screening

          -  If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of
             prednisone/day for at least 2 weeks prior to first administration of study agent

          -  Are considered eligible according to specified tuberculosis (TB) screening criteria

        Exclusion Criteria:

          -  Have inflammatory diseases other than RA that might confound the evaluation of the
             benefit of golimumab therapy

          -  Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
             immunosuppressives other than MTX, during the 4 weeks prior to the first
             administration of study agent

          -  Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs
             (infliximab, etanercept, adalimumab)

          -  Have had history of, or ongoing, chronic or recurrent infectious disease.

          -  Have serious infection within 2 months prior to first administration of study agent

          -  Have a history of latent or active granulomatous infection, including TB,
             histoplasmosis, or coccidioidomycosis, prior to screening