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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn Disease

Intervention: Sargramostim (Leukine) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

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.

Clinical Details

Official title: Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (LeukineŽ) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Proportion of patients achieving clinical response or remission

Secondary outcome: Proportion of patients achieving clinical response or remission

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

San Francisco, California 94117, United States

Atlanta, Georgia 30342, United States

New Orleans, Louisiana 70118-5799, United States

Boston, Massachusetts 02114-2696, United States

Morristown, New Jersey 07962-1956, United States

Philadelphia, Pennsylvania 19104-4399, United States

Houston, Texas 77030, United States

Additional Information

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Starting date: July 2004
Last updated: December 2, 2013

Page last updated: August 23, 2015

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