Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

• Status: Terminated
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.