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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

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 2

Status: Completed

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 the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

Clinical Details

Official title: Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease

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

Primary outcome: Corticosteroid-free remission

Secondary outcome:

Steroid-free remission or response to treatment as defined by the protocol

Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)

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: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

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Starting date: July 2003
Last updated: December 2, 2013

Page last updated: August 23, 2015

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