Ulcerative Colitis |
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Clinical Trial: A Long Term Safety Study of Infliximab (Remicade)
This study is not yet open for patient recruitment.
Verified by Centocor Research & Development, Inc., PA, USA September 2005
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Purpose
| Condition | Phase |
|---|---|
| Colitis, Ulcerative | Phase IV |
MedlinePlus related topics: Ulcerative Colitis
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: A Multicenter International Study of the Long-Term Safety of Infliximab (REMICADE) in Ulcerative Colitis
This study is to collect long-term safety information on infiximab (Remicade), from subjects who participate in research studies using this drug. The primary studies include C0168T37 and C0168T46. All subjects who had at least one dose of study drug in those studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab (Remicade) after the end of the primary study. In addition, information will be collected if patients have had any surgery for ulcerative colitis, and to see if patients have had any worsening of ulcerative colitis that required hospitalization since patients studies. Information on colonoscopies will also be collected, for those patients that were considered to have a high risk for dysplasia in the beginning of the original studies and have had a follow-up colonoscopy. Participation in this research study is 5 years after the end of the primary study. Questionnaires about patients health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after completed participation in the primary study.
No drug is provided
Eligibility
Inclusion Criteria: - All subjects enrolled in ongoing and future Centocor-sponsored 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
Exclusion Criteria: - Did not previously participate in Centocor sponsored infliximab clinical studies.
Location and Contact Information
Centocor Research & Development, Inc., PA, USA Clinical Trial, Study Director, Centocor Research & Development, Inc., PA, USA
More Information
Last Updated: September 20, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00207688
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27

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