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 intolerance to conventional therapy for Crohn's Disease.
Anti-IP10: Anti Interferon-inducible ligand 10
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Clinical remission (CDAI score of <150)
CDAI: Crohn's Disease Activity Index
Time frame: Week 11
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Time frame: Week 7 and Week 11
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
Time frame: Week 7 and Week 11
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Week 11
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values
AE - Adverse Event SAE - Serious Adverse Event
Time frame: Week 11
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Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Southern California Medical Gastroenterology Group
Santa Monica, California, United States
Shafran Gasteroenterology Center
Winter Park, Florida, United States
Gastroenterology Research Of New Orleans
Hammond, Louisiana, United States
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, United States
Midwest Center For Clinical Research
Lees Summit, Missouri, United States
Nyu Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Mount Sinai School Of Medicine
New York, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
Gastroenterology Research Of San Antonio
San Antonio, Texas, United States
...and 23 more locations