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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Sargramostim (Leukine)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sargramostim (Leukine)<br>* Once daily via subcutaneous injection for up 22 weeks<br>* Other names: BAY86-5326;|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Once daily via subcutaneous injection for up 22 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticosteroid-free remission |  | At the end of the study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |