Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00206674
First received: September 13, 2005
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.


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
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Induction of clinical response and/or remission as defined by decrease in CDAI score [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time and duration to response/remission [ Time Frame: During the 8 weeks of treatment ] [ Designated as safety issue: No ]
  • QoL (different methods) [ Time Frame: During the whole study ] [ Designated as safety issue: No ]
  • Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.) [ Time Frame: About 20 months ] [ Designated as safety issue: Yes ]

Enrollment: 286
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
Other Name: BAY86-5326
Placebo Comparator: Arm 2 Drug: Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable but active Crohn's disease at the time of screening
  • Must be able to self-inject or have another person who can help with the injection

Exclusion Criteria:

  • Not have a colostomy or ileostomy
  • Not be taking prohibited medications as defined in the protocol
  • Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
  • 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: NCT00206674

  Show 70 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00206674     History of Changes
Obsolete Identifiers: NCT00185497
Other Study ID Numbers: 308380, 91405, Novel 4
Study First Received: September 13, 2005
Last Updated: December 2, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Sanofi:
Morbus Crohn
Sargramostim
Phase III
Placebo Controlled

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

ClinicalTrials.gov processed this record on April 17, 2014