Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00206713
• Other study ID #: 308180
• Secondary ID: 91404Novel 3
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 2, 2013
• Start date: July 2004
• Est. completion date: October 2006

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 264
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Sargramostim (Leukine)
6 µg/kg sargramostim administered SC once daily for 8 weeks
• Placebo
Placebo administered SC once daily during the randomized retreatment phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving clinical response or remission		At Day 57 of the randomized retreatment phase	No
Secondary	Proportion of patients achieving clinical response or remission		At the end of Week 8 of the open-label phase.	No

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