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

Completed · 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 ulcerative colitis (UC).

Key facts

Study ID

NCT00487539

Run by

Janssen Research & Development, LLC

People needed

1065

Starts

2007-08-01

Expected to finish

2010-10-01

Last updated by the study team

2014-02-17

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, oral corticosteroids, 6-mercaptopurine and azathioprine
• 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 tuberculosis
• Participants with negative stool test for enteric (by way of the intestines) pathogens

You may not qualify if…

• Participants with prior 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 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 — Little Rock, Arkansas, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Golden, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Naples, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Clive, Iowa, United States
• Study site — Pratt, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Monroe, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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