Open-Label Trial of LEUKINE® in Active Crohn's Disease

Condition(s) targeted: Crohn Disease

Intervention: Sargramostim (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Clinical Research Center, Study Director, Affiliation: clinical-trials-contact@bayerhealthcare.com

The purpose of this study is to establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn’s disease.

Official title: Open-Label Trial of LEUKINE® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn’s Disease

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Primary outcome: Establish a safety provide for long-term repeated cycles of sargramostim administered to patients with Crohn's disease

Secondary outcome:

Crohn’s disease activity in after successive 8-week cycles of treatment

Duration of clinical remission and time to disease flare after successive cycles of sargramostim therapy

Patient compliance with successive cycles of the 8 week treatment regimen

Changes in concomitant Crohn’s disease medication use over the treatment period and through the follow-up period

Detailed description: This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc. and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- able to give informed consent

- age 18 years or older

- stable but active Crohn’s disease at the time of screening

- must be able to self-inject or have another person who can help with the injection

- must not be pregnant and agree to use birth control if sexually active male or female

of childbearing potential

- participate in a prior study of Leukine in Patients with Crohn’s disease sponsored by

drug manufacturer

Exclusion Criteria:

- not pregnant or breastfeeding

- not have a colostomy or ileostomy

- not be taking prohibited medications as defined in the protocol

- not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery

for the next months

- not have ever taken this drug or drugs of similar type in the past

- allergy to yeast

This study is the same study protocol as NCT00185471, with different locations.

Starting date: January 2003
Last updated: June 26, 2007