NCT00488774

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 291 (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 active ulcerative colitis (UC) (sores in the colon).

Detailed description

This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions \[treatments\]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. 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 at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
OTHER	Placebo	Matching placebo for golimumab, intravenous infusion administered at Week 0
DRUG	Golimumab 1 mg per kg	Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
DRUG	Golimumab 2 mg per kg	Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
DRUG	Golimumab 4 mg per kg	Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-06-20
• Last updated: 2013-06-14
• Results posted: 2013-06-14

Locations

108 sites across 22 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Israel, Latvia, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, Sweden, Ukraine