Status:
COMPLETED
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Lead Sponsor:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Prot...
Eligibility Criteria
Inclusion
- Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Exclusion
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- Previous history of listeria infection or untreated tuberculosis
- Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
777 Patients enrolled
Trial Details
Trial ID
NCT00195715
Start Date
September 1 2004
End Date
December 1 2008
Last Update
July 12 2011
Active Locations (111)
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1
Site Ref # / Investigator 1894
Huntsville, Alabama, United States, 35801
2
Site Ref # / Investigator 1895
Jacksonville, Alabama, United States, 35801
3
Site Ref # / Investigator 1787
La Jolla, California, United States, 92037
4
Site Ref # / Investigator 1902
Roseville, California, United States, 95661