At a glance
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A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)
In Brief
A Phase 3 clinical trial evaluating Golimumab 50 mg SC, Golimumab 2 mg/kg IV, and 3 other interventions for Arthritis and 2 related conditions. Completed, enrolled 433 participants across 117 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.