This is a Phase II study of the safety and efficacy of TAK-603/A-165646 in patients with crohn's disease. The primary efficacy endpoint of this study will be a percentage of patients achieving remission, defined as a CDAI score of 150 or less. Secondary endpoints will include percentage of patients achieving improvement in symptions, indicated by a reduction in baseline CDAI by at least 50 points, percentage of patients classified as treatment failure, and changes in physicians global assessment of disease activity, patients global assessment of disease activity, laboratory measure of inflammatory activity and qualify of life evaluations.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000046-39S2
Application #
6263881
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
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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