Status:
COMPLETED
Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intoler...
Detailed Description
Anti-IP10: Anti Interferon-inducible ligand 10
Eligibility Criteria
Inclusion
- Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
- Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
- In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)
Exclusion
- Ulcerative colitis (UC) or indeterminate colitis
- Short bowel syndrome
- Known stricture or noninflammatory stenosis leading to symptoms of obstruction
- Current stoma or current need for colostomy or ileostomy
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01466374
Start Date
December 1 2011
End Date
December 1 2014
Last Update
October 12 2015
Active Locations (33)
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1
Southern California Medical Gastroenterology Group
Santa Monica, California, United States, 90404
2
Shafran Gasteroenterology Center
Winter Park, Florida, United States, 32789
3
Gastroenterology Research Of New Orleans
Hammond, Louisiana, United States, 70403
4
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, United States, 20815