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Study of Sargramostim in Moderately to Severely Active Crohn's Disease

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329537
First Posted: May 24, 2006
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
May 23, 2006
May 24, 2006
December 4, 2013
June 2006
May 2007   (Final data collection date for primary outcome measure)
CDAI [Crohn's Disease Active Index] improvements [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]
CDAI [Crohn's Disease Active Index] improvements
Complete list of historical versions of study NCT00329537 on ClinicalTrials.gov Archive Site
  • PRO [Patient-reported outcome] variables (QOL [Quality of life] [ Time Frame: Baseline, 1w, 4w, 8w, 12w ]
  • PGI-C [Patient global impression of change]) [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]
  • PRO [Patient-reported outcome] variables (QOL [Quality of life]
  • PGI-C [Patient global impression of change])
Not Provided
Not Provided
 
Study of Sargramostim in Moderately to Severely Active Crohn's Disease
Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)
The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: Sargramostim (Leukine)
    Self-subcutaneous injection
    Other Name: BAY86-5326
  • Drug: Placebo
    Self-subcutaneous injection
  • Experimental: Arm 1
    Intervention: Drug: Sargramostim (Leukine)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
  • Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index [CDAI] >220 and <475 points)

Exclusion Criteria:

  • Colostomy or ileostomy
  • Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
  • GI surgery within 6 months prior to receiving the 1st dose of study drug
  • Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00329537
309240
91510
No
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP