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Open-label Trial of Leukine in Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00206700
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Crohn Disease Drug: Sargramostim (Leukine) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
Study Start Date : February 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Name: BAY86-5326

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Crohn's disease activity [ Time Frame: After successive 8-week cycles of treatment ]
  2. Duration of clinical remission and time to disease flare [ Time Frame: After successive cycles of sargramostim therapy ]
  3. Patient compliance [ Time Frame: After successive cycles of sargramostim therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206700

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Sponsors and Collaborators
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00206700    
Obsolete Identifiers: NCT00185471
Other Study ID Numbers: 307340
Novel 5
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs