A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

Completed · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

Key facts

Study ID

NCT00207688

Run by

Janssen Research & Development, LLC

People needed

505

Starts

2004-08-31

Expected to finish

2015-09-09

Last updated by the study team

2018-07-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
• Patients must have received at least 1 dose of study agent to be eligible for participation in the study

You may not qualify if…

• Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation

Where it is running

• Study site — Anaheim, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Laurel, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Plymouth, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Egg Harbor, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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