NCT00487539

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,065 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multi-center (conducted in more than one center), randomized (study medication assigned by chance), double-blind (neither the physician nor the participant know about the study medication), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study to evaluate the safety and efficacy of golimumab in participants with moderately to severely active UC. There are 2 parts in this study. Part 1 is "Phase 2 dose-ranging" portion of study. Participants enrolled in Part 1, will receive subcutaneous (under the skin by way of a needle) injections of placebo, golimumab 100 milligram (mg), 200 mg, or 400 mg at Week 0, followed by subcutaneous injections of placebo, golimumab 50 mg, 100 mg, or 200 mg respectively at Week 2. Part 2 is "Phase 3 dose-confirming" portion of study and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety 16 weeks after last administration of study agent. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks after last administration of study agent for participants who do not enter the 1-year golimumab maintenance study. Efficacy of the participants will primarily be evaluated by clinical response at Week 6. Participants' safety will be monitored throughout the study.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
BIOLOGICAL	Golimumab 100 mg	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.
BIOLOGICAL	Golimumab 200 mg	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.
BIOLOGICAL	Golimumab 400 mg	Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group.
BIOLOGICAL	Golimumab 50 mg	Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -\> 50 mg arm group.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-06-18
• Last updated: 2014-02-17
• Results posted: 2014-02-17

Locations

200 sites across 25 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, India, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Sweden, Ukraine