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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
264
6 μg/kg sargramostim administered SC once daily for 8 weeks
Placebo administered SC once daily during the randomized retreatment phase.
Unnamed facility
San Francisco, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Boston, Massachusetts, United States
Proportion of patients achieving clinical response or remission
Time frame: At Day 57 of the randomized retreatment phase
Proportion of patients achieving clinical response or remission
Time frame: At the end of Week 8 of the open-label phase.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Morristown, New Jersey, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States