Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
NCT ID: NCT00206713
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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TERMINATED
PHASE3
264 participants
INTERVENTIONAL
2004-07-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Sargramostim (Leukine)
6 μg/kg sargramostim administered SC once daily for 8 weeks
Arm 2
Placebo
Placebo administered SC once daily during the randomized retreatment phase.
Interventions
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Sargramostim (Leukine)
6 μg/kg sargramostim administered SC once daily for 8 weeks
Placebo
Placebo administered SC once daily during the randomized retreatment phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 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
Locations
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San Francisco, California, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Morristown, New Jersey, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Countries
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Other Identifiers
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91404
Identifier Type: -
Identifier Source: secondary_id
Novel 3
Identifier Type: -
Identifier Source: secondary_id
308180
Identifier Type: -
Identifier Source: org_study_id