Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00105300
- Lead Sponsor
- Abbott
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
- History of certain types of cancer
- Diagnosis of ulcerative colitis
- Pregnant female or breast feeding subjects
- Known obstructive strictures
- Surgical bowel resection in the past 6 months
- History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
- History of poorly controlled medical conditions
- Specific doses and durations of Crohn's medications
- Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Induction of clinical remission (CDAI score < 150 at Week 4)
- Secondary Outcome Measures
Name Time Method Changes in IBDQ scores 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
Trial Locations
- Locations (56)
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
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