Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

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

Details

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

Criteria

Inclusion Criteria:

• Stable but active Crohn's disease at the time of screening

• Must be able to self-inject or have another person who can help with the injection

Exclusion Criteria:

• Not have a colostomy or ileostomy

• Not be taking prohibited medications as defined in the protocol

• Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months

• Not have ever taken this drug or drugs of similar type in the past