Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206713

Enrollment

264

Registered

2005-09-21

Start date

2004-07-31

Completion date

2006-10-31

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn Disease

Brief summary

The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.

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.

Interventions

DRUGSargramostim (Leukine)

6 μg/kg sargramostim administered SC once daily for 8 weeks

DRUGPlacebo

Placebo administered SC once daily during the randomized retreatment phase.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* You must be 18 years or older. * You must have active Crohn's disease at the time of screening. * You must be 18 years or older. * You must have active Crohn's disease at the time of screening. * You must be able to give yourself an injection of study drug or have another person who can help you give the injection. * You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion criteria

* You may not be pregnant or breastfeeding. * You may not have a colostomy or ileostomy. * You may not be taking prohibited medications. * You may not have had GI surgery or a bowel obstruction in the last 6 months. * You may not have ever taken this drug or drugs of similar type in the past.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving clinical response or remission	At Day 57 of the randomized retreatment phase

Secondary

Measure	Time frame
Proportion of patients achieving clinical response or remission	At the end of Week 8 of the open-label phase.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026