The purpose of primary objective of this study is to evaluate the safety, tolerance and efficacy of SCH 52000 in steroid dependent Crohn's Disease patients. Safety means the presence absence of harmful side effects resulting from using the drug; Tolerance means the ability for patients to take the medication over a period of time; Efficacy means the drug's ability to produce beneficial effects on the course or duration of a disease; Steroid dependent means that there has been at least one attempt to wean you off coricosteroid and it has proven to be unsuccessful. Because of the risks of long-term use of steroids, doctors are trying to find therapies which can help people to taper off steroids. The second purpose of the study is to: 1) evaluate the ability of SCH 52000 to get patients off steroids before or within 16 weeks of beginning study drug 2) evaluate the time (if any) for the need to restart steroids or other therapy for the management of Crohn's disease or dropping from the study for side effects. 3) evaluate the effect of SCH 52000 on the Health-Related Quality of Life (a questionnaire) at the end of 28 weeks of treatment and at the end of Follow-up Week 8. 4) evaluated patients continued response to the study drug after 8 weeks without the drug.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000046-40
Application #
6413994
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1974-10-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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