Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis CNTO 148 Methotrexate Joint pain Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Detailed description:
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Golimumab intervention 2: MTX intervention 3: Placebo intervention 4: Infliximab
Intervention descriptions: intervention 1: Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous. intervention 2: Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous intervention 3: Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous intervention 4: Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Protocol document: