Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206596

Enrollment

127

Registered

2005-09-21

Start date

2003-07-31

Completion date

2005-10-31

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

Brief summary

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for 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.

Interventions

DRUGSargramostim (Leukine)

Once daily via subcutaneous injection for up 22 weeks

DRUGPlacebo

Once daily via subcutaneous injection for up 22 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening. * You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease). * You must be able to give yourself an injection of study drug or have another person 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 taking medications not allowed on this study. * You may not have had GI surgery or 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
Corticosteroid-free remission	At the end of the study treatment

Secondary

Measure	Time frame
Steroid-free remission or response to treatment as defined by the protocol	At the end of the study treatment
Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)	At the end of the study treatment

Outcome results

None listed

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