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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00329537
First received: May 23, 2006
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

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

Further study details as provided by Genzyme:

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
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
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: NCT00329537     History of Changes
Other Study ID Numbers: 309240, 91510
Study First Received: May 23, 2006
Last Updated: March 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Keywords provided by Genzyme:
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 May 19, 2013