At a glance
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A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Placebo, Golimumab 100 mg, and 3 other interventions for Colitis, Ulcerative. Completed, enrolled 1,065 participants across 200 sites in 25 countries.
Detailed Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
Study Details
Timeline
Interventions
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -\> 50 mg arm group and at Week 2 for Golimumab 200 mg -\> 100 mg arm group.
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -\> 100 mg arm group and at Week 2 for Golimumab 400 mg -\> 200 mg arm group.
Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group.
Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -\> 50 mg arm group.