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
NCT ID: NCT00206596
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2003-07-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Sargramostim (Leukine)
Once daily via subcutaneous injection for up 22 weeks
Arm 2
Placebo
Once daily via subcutaneous injection for up 22 weeks
Interventions
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Sargramostim (Leukine)
Once daily via subcutaneous injection for up 22 weeks
Placebo
Once daily via subcutaneous injection for up 22 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Countries
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References
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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.
Other Identifiers
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91282
Identifier Type: -
Identifier Source: secondary_id
Novel 2
Identifier Type: -
Identifier Source: secondary_id
307501
Identifier Type: -
Identifier Source: org_study_id