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 - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206596

Purpose

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

Condition	Intervention	Phase
Crohn Disease	Drug: Sargramostim (Leukine, BAY86-5326) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Corticosteroid-free remission [ Time Frame: At the end of the study treatment ]

Secondary Outcome Measures:

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

Enrollment:	127
Study Start Date:	July 2003
Study Completion Date:	October 2005

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sargramostim (Leukine, BAY86-5326) Once daily via subcutaneous injection for up 22 weeks
Arm 2: Placebo Comparator	Drug: Placebo Once daily via subcutaneous injection for up 22 weeks

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206596

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91282, 307501, Novel 2
Study First Received:	September 12, 2005
Last Updated:	July 3, 2009
ClinicalTrials.gov Identifier:	NCT00206596 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Ileal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on September 11, 2009