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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

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ClinicalTrials.gov Identifier: NCT00206713
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Sargramostim (Leukine) Drug: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2004
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients achieving clinical response or remission [ Time Frame: At Day 57 of the randomized retreatment phase ]

Secondary Outcome Measures :
  1. Proportion of patients achieving clinical response or remission [ Time Frame: At the end of Week 8 of the open-label phase. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information

Additional Information:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00206713     History of Changes
Other Study ID Numbers: 308180
91404
Novel 3
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Crohn Disease

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