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

Study Overview
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Brief Summary
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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.

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

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 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.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sargramostim (Leukine)<br>* 6 μg/kg sargramostim administered SC once daily for 8 weeks<br>* Other names: BAY86-5326;|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo administered SC once daily during the randomized retreatment phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving clinical response or remission |  | At Day 57 of the randomized retreatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving clinical response or remission |  | At the end of Week 8 of the open-label phase. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease