A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab 2 mg/kg IV
Intervention description: Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Intervention MeSH terms: Golimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Arthritis, Rheumatoid

Summary:

      This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects
      with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease
      control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in
      28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα
      therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg
      every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.

      To be eligible for participation, subjects must have previously demonstrated initial and/or
      temporary improvement in disease signs and symptoms, who have since exhibited a diminished
      response despite continued treatment. It is estimated that 200 subjects will be enrolled in
      the study at approximately 85 global sites.
    

Eligibility criteria:

        Major Inclusion Criteria include (but not limited to):

          -  Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of
             the American Rheumatism Association).

          -  Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of
             methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy
             with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg
             every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).

          -  Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR)
             at Week -8 and Week 0.

          -  Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week
             0.

          -  Prior response confirmed by physician.

        Major Exclusion Criteria include (but not limited to):

          -  Have a history of latent or active granulomatous infection, including histoplasmosis,
             or Have a history of latent or active granulomatous infection, including
             histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during
             the Screening Period.

          -  Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.

          -  Have a chest radiograph within 3 months prior to the first administration of study
             agent that shows an abnormality suggestive of a malignancy or current active
             infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.

          -  Have previously received more than 1 of the currently approved subcutaneous (SC)
             administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or
             adalimumab.

          -  Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months
             after receiving the last administration of the study agent.

          -  Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242
             pounds).