Study of Sargramostim in Moderately to Severely Active Crohn's Disease - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00329537

Purpose

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.

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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

Further study details as provided by Bayer:

Primary Outcome Measures:

CDAI [Crohn's disease active index] improvements [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]

Secondary Outcome Measures:

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

Enrollment:	66
Study Start Date:	June 2006
Study Completion Date:	May 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Leukine (Sargramostim, BAY86-5326) Self-subcutaneous injection
Arm 2: Placebo Comparator	Drug: Placebo Self-subcutaneous injection

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329537

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Yakuhin Ltd. ( Head Clinical Pharmacology )
Study ID Numbers:	91510, 309240, A36774
Study First Received:	May 23, 2006
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00329537
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Crohn's disease
sargramostim
CDAI
Moderately to severely active Crohn's disease

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 15, 2009