Status:
COMPLETED
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
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 if Leukine can induce clinical response or remission in patients with Crohn's disease.
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
- Stable but active Crohn's disease at the time of screening
- Must be able to self-inject or have another person who can help with the injection
Exclusion
- Not have a colostomy or ileostomy
- Not be taking prohibited medications as defined in the protocol
- Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
- Not have ever taken this drug or drugs of similar type in the past
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00206674
Start Date
September 1 2004
End Date
June 1 2006
Last Update
December 4 2013
Active Locations (70)
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1
Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
2
Buenos Aires, Buenos Aires F.D., Argentina, C1264AAA
3
Garran, Australian Capital Territory, Australia, 2605
4
Concord, New South Wales, Australia, 2139