Open-Label Trial of Leukine in Active Crohn's Disease - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206700

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Open-Label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active 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:

To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease. [ Time Frame: Not applicable for this outcome ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Crohn's disease activity [ Time Frame: After successive 8-week cycles of treatment ] [ Designated as safety issue: No ]
Duration of clinical remission and time to disease flare [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]
Patient compliance [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]

Enrollment:	378
Study Start Date:	February 2003
Study Completion Date:	December 2006

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sargramostim (Leukine, BAY86-5326) Open Label, 8 week cycle

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.

Eligibility

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

Criteria

Inclusion Criteria:

Able to provide informed consent
Participated in a previous study of sargramostim in Crohn's disease within the past 12 months
Subjects who participated in protocols excluding concomitant steroid use:
Must have moderately to severely active Crohn's disease at time of screening (CDAI score >/= 220 points and less than or equal to 475 points)
Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening if treated with corticosteroids between completing their previous sargramostim study and entry into this study and be able to taper to less than or equal to 7.5 mg daily within one treatment cycle
Subjects who participated in Protocol 307501
Must have active Crohn's disease (CDAI score > 150 points and less than or equal to 450 points) if completely withdrawn from CS use
Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening, be able to taper to less than or equal to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use
Have a negative serum pregnancy test within 2 weeks prior to receiving initial dose of sargramostim in female subjects of child-bearing potential (optional - may be waived by the investigator if the subject has had no interruption in contraception method since participation in the previous study)
Agree to use of an adequate method of contraception throughout the study period for sexually-active males and females of childbearing potential
Able to self-inject sargramostim or have a designee who can do so
Able to comply with protocol requirements
Have a negative stool exam if subject received a course of antibiotics since participation in the previous study

Exclusion Criteria:

Pregnant or breastfeeding female
Need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
Gastrointestinal surgery within the prior 6 months
Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
Serum creatinine greater than or equal to 2.0 mg/dL
Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin greater or equal to 2X the upper limit of normal; hemoglobin (Hb) < 8.0 gm/dL; platelet count greater than or equal to 800,000/mL; ANC less than or equal to 1,000/µL or > 20,000/µL (the exclusion of subjects with ANC > 20,000/µL applies only to entry into the first treatment cycle)
Use of licensed/registered anti-tumor necrosis factor (TNF) therapy such as infliximab within 8 weeks prior to first dose of study drug in this trial
Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug:

6-mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide
Use of any experimental agent in a clinical trial since participating in a sargramostim trial
History of allergy to yeast products or sargramostim
Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent
Clinically important primary disease unrelated to Crohn's disease
Prior exposure to natalizumab (Tysabri)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206700

Show 167 Study Locations

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91274, 307340, Novel 5
Study First Received:	September 13, 2005
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00206700 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
Molgramostim
Gastroenteritis
Intestinal Diseases
Ileal Diseases

Additional relevant MeSH terms:

Ileitis
Gastrointestinal Diseases
Antineoplastic Agents
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Molgramostim

Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on September 11, 2009