Status:
COMPLETED
Adalimumab for the Induction and Maintenance 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 purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substanc...
Eligibility Criteria
Inclusion
- Inclusion:
- Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of \>= 220 and \<= 450, normal laboratory parameters,
- are willing and able to give informed consent, and
- are able to self-inject or have a designee or healthcare professional who can inject the study medication.
- Exclusion:
- History of certain types of cancer, diagnosis of ulcerative colitis,
- female or breast feeding subjects,
- surgical bowel resection(s) with in the past 6 months,
- history of listeria,
- human immunodeficiency virus (HIV),
- central nervous system demyelinating disease or untreated TB,
- history of a poorly controlled medical condition,
- unsuccessful response to infliximab or any anti-TNF agent use in the past.
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
854 Patients enrolled
Trial Details
Trial ID
NCT00077779
Start Date
July 1 2003
Last Update
September 26 2007
Active Locations (43)
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1
Thornton Hospital Reumatology Division
La Jolla, California, United States, 92037-0943
2
UCSF San Francisco General Hospital
San Francisco, California, United States, 94110
3
Cal-West, Inc.
San Francisco, California, United States, 94117
4
Western States Clinical Research
Arvada, Colorado, United States, 80002