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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00329537
First received: May 23, 2006
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Sargramostim (Leukine)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • CDAI [Crohn's Disease Active Index] improvements [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sargramostim (Leukine)
Self-subcutaneous injection
Other Name: BAY86-5326
Placebo Comparator: Arm 2 Drug: Placebo
Self-subcutaneous injection

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329537

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: NCT00329537     History of Changes
Other Study ID Numbers: 309240, 91510
Study First Received: May 23, 2006
Last Updated: December 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Keywords provided by Sanofi:
Crohn's Disease
Sargramostim
CDAI
Moderately to severely active Crohn's Disease

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

ClinicalTrials.gov processed this record on April 20, 2014