Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
Condition: Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases
MeSH terms: Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases
Intervention: Golimumab 50 mg SC; Golimumab 2 mg/kg IV; Methotrexate (MTX); Placebo SC; Placebo IV
Intervention description: Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.; Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.; Participants will continue taking their current Methotrexate (MTX) treatment regimen.; Placebo matched to golimumab SC injection every 4 weeks.; Placebo matched to golimumab intravenous infusion every 8 weeks.
Intervention MeSH terms: Golimumab; Methotrexate; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 433.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: humira, remicade; rheumatoid arthritis; enbrel failure; humira failure; arthritis; enbrel

Summary:

      The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid
      arthritis (RA) participants who have an inadequate response to their current treatment with
      either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50
      milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of
      upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also
      designed to evaluate the benefit and safety of switching participants from treatment with
      golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram
      per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a
      marked improvement of their RA at Week 16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have inadequate RA disease control prior to the first administration of study agent
             despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) +
             methotrexate (MTX)

          -  Must have received a stable dose of MTX greater than or equal to (>=) 7.5 milligram
             (mg) per week to less than or equal to (<=) 25 mg per week for at least 4 consecutive
             weeks prior to the first screening visit and must plan to maintain that dose
             throughout the study

          -  Participants must have received etanercept or adalimumab in combination with MTX for a
             minimum of 3 months prior to the first visit

          -  Negative tuberculosis (TB) test

          -  Are capable of providing informed consent, which must be obtained prior to any
             study-related procedures

        Exclusion Criteria:

          -  Have a history of latent or active granulomatous infection, including TB,
             histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals
             who carry active TB infection

          -  Have inflammatory diseases other than RA, including but not limited to psoriatic
             arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or
             Lyme disease

          -  Have demonstrated a discernible improvement in disease activity between screening and
             prior to the first golimumab injection at Week 0

          -  Have any known malignancy or have a history of malignancy within the previous 5 years
             (with the exception of a nonmelanoma skin cancer that has been treated with no
             evidence of recurrence)

          -  Have a history of lymphoproliferative disease, including lymphoma, or signs and
             symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of
             unusual size or location