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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Louisiana
      • New Orleans, Louisiana, United States, 70118-5799
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2696
    • New Jersey
      • Morristown, New Jersey, United States, 07962-1956
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4399
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Sargramostim (Leukine)
6 μg/kg sargramostim administered SC once daily for 8 weeks
Other Names:
  • BAY86-5326
PLACEBO_COMPARATOR: Arm 2
Drug: Placebo
Placebo administered SC once daily during the randomized retreatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving clinical response or remission
Time Frame: At Day 57 of the randomized retreatment phase
At Day 57 of the randomized retreatment phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving clinical response or remission
Time Frame: At the end of Week 8 of the open-label phase.
At the end of Week 8 of the open-label phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308180
  • 91404
  • Novel 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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