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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID: NCT00206713
Run by: Genzyme, a Sanofi Company
People needed: 264
Starts: 2004-07-01
Expected to finish: 2006-10-01
Last updated by the study team: 2013-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Study site — San Francisco, California, United States
Study site — Atlanta, Georgia, United States
Study site — New Orleans, Louisiana, United States
Study site — Boston, Massachusetts, United States
Study site — Morristown, New Jersey, United States
Study site — Philadelphia, Pennsylvania, United States
Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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