Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim
3 other identifiers
interventional
264
1 country
7
Brief Summary
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2004
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 4, 2013
December 1, 2013
2.3 years
September 13, 2005
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving clinical response or remission
At Day 57 of the randomized retreatment phase
Secondary Outcomes (1)
Proportion of patients achieving clinical response or remission
At the end of Week 8 of the open-label phase.
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
6 μg/kg sargramostim administered SC once daily for 8 weeks
Eligibility Criteria
You may qualify if:
- You must be 18 years or older.
- 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.
You may not qualify if:
- You may not be pregnant or breastfeeding.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
New Orleans, Louisiana, 70118-5799, United States
Unknown Facility
Boston, Massachusetts, 02114-2696, United States
Unknown Facility
Morristown, New Jersey, 07962-1956, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104-4399, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
July 1, 2004
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
December 4, 2013
Record last verified: 2013-12