Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease
Status and phase
Completed
Phase 2
Conditions
Crohn Disease
Treatments
Drug: Sargramostim (Leukine)
Drug: Placebo
Details and patient eligibility
About
The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.
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
127 patients
Sex
All
Ages
18 to 80 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.
- You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
- You must be able to give yourself an injection of study drug or have another person 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 taking medications not allowed on this study.
- You may not have had GI surgery or 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
Triple Blind
127 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
0
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Data sourced from clinicaltrials.gov
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