Back to resultsStudy in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sargramostim (Leukine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Corticosteroid-free remission
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00206596
First Posted
September 12, 2005
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00206596
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sargramostim (Leukine)
Other Intervention Name(s)
BAY86-5326
Intervention Description
Once daily via subcutaneous injection for up 22 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily via subcutaneous injection for up 22 weeks
Primary Outcome Measure Information:
Title
Corticosteroid-free remission
Time Frame
At the end of the study treatment
Secondary Outcome Measure Information:
Title
Steroid-free remission or response to treatment as defined by the protocol
Time Frame
At the end of the study treatment
Title
Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)
Time Frame
At the end of the study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19505878
Citation
Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ. Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Gut. 2009 Oct;58(10):1354-62. doi: 10.1136/gut.2008.165738. Epub 2009 Jun 7.
Results Reference
derived
Learn more about this trial
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
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