Status:
TERMINATED
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
Detailed Description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
Eligibility Criteria
Inclusion
- You must be 18 years or older.
- You must have active Crohn's disease at the time of screening.
- You must be 18 years or older.
- You must have active Crohn's disease at the time of screening.
- You must be able to give yourself an injection of study drug or have another person who can help you give the injection.
- You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.
Exclusion
- You may not be pregnant or breastfeeding.
- You may not have a colostomy or ileostomy.
- You may not be taking prohibited medications.
- You may not have had GI surgery or a bowel obstruction in the last 6 months.
- You may not have ever taken this drug or drugs of similar type in the past.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00206713
Start Date
July 1 2004
End Date
October 1 2006
Last Update
December 4 2013
Active Locations (7)
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1
San Francisco, California, United States, 94117
2
Atlanta, Georgia, United States, 30342
3
New Orleans, Louisiana, United States, 70118-5799
4
Boston, Massachusetts, United States, 02114-2696