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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):
Genzyme
ClinicalTrials.gov Identifier:
NCT00206674
First received: September 13, 2005
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

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

Further study details as provided by Genzyme:

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
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
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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: NCT00206674     History of Changes
Obsolete Identifiers: NCT00185497
Other Study ID Numbers: 308380, 91405, Novel 4
Study First Received: September 13, 2005
Last Updated: March 6, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Genzyme:
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 May 21, 2013