A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo injections; Placebo capsules; Methotrexate capsules; Golimumab 50 mg injections; Golimumab 100 mg injections
Intervention description: SC injections; Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).; Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.; SC injections; SC injections
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: 637.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Methotrexate Naïve; subcutaneous injection

Summary:

      The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in
      combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis
      subjects who have not been previously treated with methotrexate.
    

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 first administration of study agent

          -  Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX
             for RA at any time)

          -  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 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.

        Exclusion Criteria:

          -  Can not have inflammatory diseases other than RA that might confound the evaluation of
             the benefit of golimumab therapy

          -  No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
             immunosuppressives during the 4 weeks prior to the first administration of study agent

          -  No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)

          -  No history of, or ongoing, chronic or recurrent infectious disease

          -  No serious infection within 2 months prior to first administration of study agent.