Study of Sargramostim in Moderately to Severely Active Crohn's Disease
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Sargramostim (Leukine) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
Summary
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: CDAI [Crohn's Disease Active Index] improvements
Secondary outcome: PRO [Patient-reported outcome] variables (QOL [Quality of life]PGI-C [Patient global impression of change])
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
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Starting date: June 2006
Last updated: December 2, 2013
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