Status:
COMPLETED
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
Lead Sponsor:
Shire
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
Detailed Description
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
Eligibility Criteria
Inclusion
- Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
- Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- CDAI score greater than 220
- Stool samples not required
- C-reactive protein levels are not an exclusion criterion
Exclusion
- Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00308438
Start Date
March 1 2004
End Date
June 1 2006
Last Update
May 14 2021
Active Locations (24)
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1
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
2
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States, 80401
3
Rx Trials
Washington D.C., District of Columbia, United States, 20010
4
Clinical Trials Management of Boca Raton
Boca Raton, Florida, United States, 33486