The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Induction of clinical remission (CDAI score < 150 at Week 4)
Clinical response measured as
Decrease in Baseline CDAI score >= 70 points at Week 4
Decrease in Baseline CDAI score >= 100 points at Week 4
Changes in IBDQ scores at Week 4
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Clinical Research Associates
Huntsville, Alabama, United States
Capitol Gastroenterology Consultants Medical Group, Inc.
Roseville, California, United States
Medical Associates Research Group
San Diego, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
SMC-Trauma Research
Englewood, Colorado, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, United States
V.A. Medical Center
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, United States
...and 46 more locations