Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206596
• Other study ID #: 307501
• Secondary ID: 91282Novel 2
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 2, 2013
• Start date: July 2003
• Est. completion date: October 2005

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

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: Completed
• Enrollment: 127
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.

• You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).

• You must be able to give yourself an injection of study drug or have another person 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 taking medications not allowed on this study.

• You may not have had GI surgery or 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, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Sargramostim (Leukine)
Once daily via subcutaneous injection for up 22 weeks
• Placebo
Once daily via subcutaneous injection for up 22 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corticosteroid-free remission		At the end of the study treatment
Secondary	Steroid-free remission or response to treatment as defined by the protocol		At the end of the study treatment
Secondary	Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)		At the end of the study treatment

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