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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn Disease

Intervention: Sargramostim (Leukine) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company


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.

Clinical Details

Official title: Open-label Trial of Leukine« (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.

Secondary outcome:

Crohn's disease activity

Duration of clinical remission and time to disease flare

Patient compliance

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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450 points) if completely withdrawn from CS use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/┬ÁL or > 20,000/┬ÁL (the exclusion of subjects with ANC > 20,000/┬ÁL 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)

Locations and Contacts

Penrith 2751, Australia

Quebec G1S 4L8, Canada

Auckland 1023, New Zealand

Christchurch 8011, New Zealand

Hamilton 3204, New Zealand

Moscow 123154, Russian Federation

Moscow 129110, Russian Federation

Moskva 127015, Russian Federation

Volgograd 400107, Russian Federation

Basel 4031, Switzerland

Bern 3010, Switzerland

Donetsk 83017, Ukraine

Kharkiv 61001, Ukraine

Kiev 03049, Ukraine

Lviv 49044, Ukraine

Vinnitsa 26014, Ukraine

London WC1E 6AU, United Kingdom

Sheffield S10 2JF, United Kingdom

Birmingham, Alabama 35209, United States

Edmonton, Alberta T5H 4B9, Canada

Edmonton, Alberta T6G 2B7, Canada

Scottsdale, Arizona 85259-5404, United States

Milford, Auckland 1309, New Zealand

Garran, Australian Capital Territory 2605, Australia

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Brisbane, Queensland 4029, Australia

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Rio de Janeiro, RJ 21949 900, Brazil

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Lipetsk, Russia 398055, Russian Federation

Moskva, Russia 105203, Russian Federation

Samara, Russia 443023, Russian Federation

Sao Paulo, SP 05403-900, Brazil

São Paulo, SP 05651-901, Brazil

Adelaide, South Australia 5043, Australia

Charleston, South Carolina 29425, United States

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Starting date: February 2003
Last updated: December 2, 2013

Page last updated: August 23, 2015

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