A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.

Key facts

Study ID

NCT00265122

Run by

Centocor, Inc.

People needed

131

Starts

2004-04-01

Expected to finish

2006-10-01

Last updated by the study team

2014-02-13

Who can join

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

You may qualify if…

• Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220 and <=450
• In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.

You may not qualify if…

• Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
• Had intra-abdominal surgery within 6 months prior to entering the study
• Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6 weeks of baseline

Where it is running

• Study site — Anaheim, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Bristol, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Topeka, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Laurel, Maryland, United States
• Study site — Chesterfield, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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