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

Phase 2

Terminated

• Conditions: Crohn's Disease
• Interventions: Drug: Sargramostim (Leukine); Drug: Placebo

• Registration Number: NCT00329537
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

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.

Study Timeline

• Study First Submitted: 2006-05-23
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-24
• Study Start: 2006-06
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Sargramostim (Leukine)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
CDAI [Crohn's Disease Active Index] improvements	Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w

Secondary Outcome Measures

Name	Time	Method
PRO [Patient-reported outcome] variables (QOL [Quality of life]	Baseline, 1w, 4w, 8w, 12w
PGI-C [Patient global impression of change])	Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w