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

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ClinicalTrials.gov Identifier: NCT00206674
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
Study Start Date : September 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Induction of clinical response and/or remission as defined by decrease in CDAI score [ Time Frame: After 8 weeks of treatment ]

Secondary Outcome Measures :
  1. Time and duration to response/remission [ Time Frame: During the 8 weeks of treatment ]
  2. QoL (different methods) [ Time Frame: During the whole study ]
  3. Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.) [ Time Frame: About 20 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00206674

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Sponsors and Collaborators
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00206674    
Obsolete Identifiers: NCT00185497
Other Study ID Numbers: 308380
Novel 4
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 ):
Morbus Crohn
Phase III
Placebo Controlled
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs