Study of Sargramostim in Moderately to Severely Active Crohn's Disease
NCT ID: NCT00329537
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
PHASE2
11 participants
INTERVENTIONAL
2006-06-30
2007-05-31
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
DOUBLE
Study Groups
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Arm 1
Sargramostim (Leukine)
Self-subcutaneous injection
Arm 2
Placebo
Self-subcutaneous injection
Interventions
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Sargramostim (Leukine)
Self-subcutaneous injection
Placebo
Self-subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index \[CDAI\] \>220 and \<475 points)
Exclusion Criteria
* Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
* GI surgery within 6 months prior to receiving the 1st dose of study drug
* Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
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
Other Identifiers
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91510
Identifier Type: -
Identifier Source: secondary_id
309240
Identifier Type: -
Identifier Source: org_study_id
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