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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00206713
First received: September 13, 2005
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn Disease
 Drug: Sargramostim (Leukine)
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Proportion of patients achieving clinical response or remission [ Time Frame: At Day 57 of the randomized retreatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients achieving clinical response or remission [ Time Frame: At the end of Week 8 of the open-label phase. ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: July 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sargramostim (Leukine)
6 μg/kg sargramostim administered SC once daily for 8 weeks
Other Name: BAY86-5326
Placebo Comparator: Arm 2 Drug: Placebo
Placebo administered SC once daily during the randomized retreatment phase.

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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206713

Locations
United States, California
San Francisco, California, United States, 94117
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Louisiana
New Orleans, Louisiana, United States, 70118-5799
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2696
United States, New Jersey
Morristown, New Jersey, United States, 07962-1956
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4399
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Genzyme
ClinicalTrials.gov Identifier: NCT00206713     History of Changes
Other Study ID Numbers: 308180, 91404, Novel 3
Study First Received: September 13, 2005
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme:
Crohn Disease

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

ClinicalTrials.gov processed this record on June 17, 2013