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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00206596
First received: September 12, 2005
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Crohn Disease
Drug: Sargramostim (Leukine)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Corticosteroid-free remission [ Time Frame: At the end of the study treatment ]

Secondary Outcome Measures:
  • Steroid-free remission or response to treatment as defined by the protocol [ Time Frame: At the end of the study treatment ]
  • Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS) [ Time Frame: At the end of the study treatment ]

Enrollment: 127
Study Start Date: July 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sargramostim (Leukine)
Once daily via subcutaneous injection for up 22 weeks
Other Name: BAY86-5326
Placebo Comparator: Arm 2 Drug: Placebo
Once daily via subcutaneous injection for up 22 weeks

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206596

Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00206596     History of Changes
Other Study ID Numbers: 307501, 91282, Novel 2
Study First Received: September 12, 2005
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 14, 2014