Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Status and phase
Terminated
Phase 3
Conditions
Crohn Disease
Treatments
Drug: Placebo
Drug: Sargramostim (Leukine)
Details and patient eligibility
About
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.
Full 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.
Enrollment
264 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
264 participants in 2 patient groups, including a placebo group
Arm 1
Experimental group
Treatment:
Drug: Sargramostim (Leukine)
Arm 2
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
7
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Data sourced from clinicaltrials.gov
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