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: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Sargramostim

Criteria

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.