Status:
COMPLETED
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
Lead Sponsor:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00105300
Start Date
October 1 2004
Last Update
August 15 2006
Active Locations (56)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
Capitol Gastroenterology Consultants Medical Group, Inc.
Roseville, California, United States, 95661
3
Medical Associates Research Group
San Diego, California, United States, 92123
4
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123