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

Phase 2

Completed

• Conditions: Crohn Disease
• Interventions: Drug: Sargramostim (Leukine); Drug: Placebo

• Registration Number: NCT00206596
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Sargramostim (Leukine)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Corticosteroid-free remission	At the end of the study treatment

Secondary Outcome Measures

Name	Time	Method
Steroid-free remission or response to treatment as defined by the protocol	At the end of the study treatment
Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)	At the end of the study treatment