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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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).

Key facts

Study ID

NCT00488774

Run by

Janssen Research & Development, LLC

People needed

291

Starts

2007-08-01

Expected to finish

2009-05-01

Last updated by the study team

2013-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
• Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
• Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
• Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB

You may not qualify if…

• Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
• Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
• Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
• Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
• Participants with a history of extensive colonic resection

Where it is running

• Study site — Roseville, California, United States
• Study site — Littleton, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Fort Dodge, Iowa, United States
• Study site — Topeka, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Laurel, Maryland, United States
• Study site — Dearborn, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Mexico, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Great Neck, New York, United States
• Study site — Huntington, New York, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Kinston, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Orange, California, United States

Full record on ClinicalTrials.gov

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