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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00206674 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
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Scientific title:
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Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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286 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00206674 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Canada
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New Zealand
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Russian Federation
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Switzerland
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Ukraine
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United Kingdom
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Stable but active Crohn's disease at the time of screening
- Must be able to self-inject or have another person who can help with the injection
Exclusion Criteria:
- Not have a colostomy or ileostomy
- Not be taking prohibited medications as defined in the protocol
- Not have had GI surgery or a bowel obstruction in the last 6 months or planned
surgery for the next months
- Not have ever taken this drug or drugs of similar type in the past
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Sargramostim (Leukine)
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Drug: Placebo
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Primary Outcome(s)
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Induction of clinical response and/or remission as defined by decrease in CDAI score
[Time Frame: After 8 weeks of treatment]
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Secondary Outcome(s)
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QoL (different methods)
[Time Frame: During the whole study]
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Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
[Time Frame: About 20 months]
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Time and duration to response/remission
[Time Frame: During the 8 weeks of treatment]
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Secondary ID(s)
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308380
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Novel 4
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91405
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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