Crohn DiseasePhase 2NCT00206700
Open-label Trial of Leukine in Active Crohn's Disease
A Phase 2 study testing Sargramostim (Leukine) in people with Crohn Disease, run by Genzyme, a Sanofi Company at 167 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Sargramostim (Leukine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 167 sitesin 10 countries
- Study dates
- Feb 2003to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 150 points and less than or equal to 450 points) if completely withdrawn from CS use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to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
167 sites in 10 countries.
167 sites in 10 countries
United States98 sites
Study site
Annapolis, Maryland, 21401
Study site
Asheville, North Carolina, 28801
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Atlanta, Georgia, 30342
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Aurora, Colorado, 80045
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Bellevue, Washington, 98004
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Berkeley, California, 94705
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Berlin, New Jersey, 08009
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Billings, Montana, 59107
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Birmingham, Alabama, 35209
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Boca Raton, Florida, 33486
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Boston, Massachusetts, 02114-2696
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Bristol, Tennessee, 37620
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Chapel Hill, North Carolina, 27514
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28207
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Charlottesville, Virginia, 22908
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Chesapeake, Virginia, 23320
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Chesterfield, Michigan, 48047
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Chicago, Illinois, 60637-1470
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45220
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Cincinnati, Ohio, 45242
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Clearwater, Florida, 33765
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Columbia, South Carolina, 29203
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Dallas, Texas, 75231
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Danville, Virginia, 24541
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Englewood, Colorado, 80110
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Gainesville, Florida, 32608-1197
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Gainesville, Florida, 32610-0254
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Great Neck, New York, 11021
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Greensboro, North Carolina, 27403
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Hagerstown, Maryland, 21740
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Hanover, Pennsylvania, 17331
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Hollywood, Florida, 33021
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Indianapolis, Indiana, 46202
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Indianapolis, Indiana, 46237
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Irving, Texas, 75061
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32224
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Jacksonville, Florida, 32256
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Kingsport, Tennessee, 37660
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Lake Charles, Louisiana, 70601
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Lakewood, Colorado, 80215
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Lancaster, Pennsylvania, 17601-2644
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Lebanon, New Hampshire, 03756-0001
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Lexington, Kentucky, 40536
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Lincoln, Nebraska, 68503
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Littleton, Colorado, 80120
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Los Angeles, California, 90067
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Louisville, Kentucky, 40202
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Madison, Wisconsin, 53792
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Memphis, Tennessee, 38119
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Memphis, Tennessee, 38120
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Metairie, Louisiana, 70001
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Mexico, Missouri, 65265
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Milwaukee, Wisconsin, 53215
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Milwaukee, Wisconsin, 53226
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Mineola, New York, 11501-3987
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37232
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New York, New York, 10029
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Norfolk, Virginia, 23502
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North Miami Beach, Florida, 33162
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Oklahoma City, Oklahoma, 73104
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Orange, California, 92868
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Philadelphia, Pennsylvania, 19104-2699
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Pittsburgh, Pennsylvania, 15212
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Pittsburgh, Pennsylvania, 15213-2592
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Plymouth, Minnesota, 55446
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Portland, Oregon, 97213
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Portland, Oregon, 97225
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Portland, Oregon, 97239
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Richmond, Virginia, 23249-0002
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Rochester, New York, 14607
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Salt Lake City, Utah, 84132
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San Antonio, Texas, 78229
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San Francisco, California, 94115
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San Francisco, California, 94117
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Sayre, Pennsylvania, 18840
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Scottsdale, Arizona, 85259-5404
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Seattle, Washington, 98104
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Seattle, Washington, 98133
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Seattle, Washington, 98195
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Slidell, Louisiana, 70458
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Spokane, Washington, 99204
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St Louis, Missouri, 63110
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Syracuse, New York, 13210
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Tarzana, California, 91345
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Towson, Maryland, 21204
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Troy, Michigan, 48098
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Tulsa, Oklahoma, 74104
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Walla Walla, Washington, 99362
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Washington D.C., District of Columbia, 20010
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Wenatchee, Washington, 98801
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Wilmington, North Carolina, 28401
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Winston-Salem, North Carolina, 27103
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Winston-Salem, North Carolina, 27157
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Winter Park, Florida, 32789
Australia17 sites
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Adelaide, South Australia, 5043
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Ballarat, Victoria, 3350
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Brisbane, Queensland, 4029
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Brisbane, Queensland, 4101
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Concord, New South Wales, 2139
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Frankston, Victoria, 3199
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Fremantle, Western Australia, 6160
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Garran, Australian Capital Territory, 2605
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Launceston, Tasmania, 7250
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Melbourne, Victoria, 3065
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Melbourne, Victoria, 3128
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New Lambton Heights, New South Wales, 2305
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Parkville, Victoria, 3050
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Penrith, 2751
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Prahran, Victoria, 3181
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Sydney, New South Wales, 2050
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Sydney, New South Wales, 2200
Canada16 sites
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Edmonton, Alberta, T5H 4B9
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Edmonton, Alberta, T6G 2B7
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Hamilton, Ontario, L8N 3Z5
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Kelowna, British Columbia, V1Y 2H4
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London, Ontario, N6A 5A5
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Montreal, Quebec, H2W 1T8
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Montreal, Quebec, H3A 1A1
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Montreal, Quebec, H3G 1A4
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Montreal, Quebec, H3T 1E2
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Québec, Quebec, G1S 4L8
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Toronto, Ontario, M3N 2V7
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Toronto, Ontario, M5G 1X5
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Vancouver, British Columbia, V5Z 1H2
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Vancouver, British Columbia, V6Z 2K5
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Windsor, Ontario, N9A 1L9
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Winnipeg, Manitoba, R3A 1R9
United Kingdom10 sites
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Bristol, Avon, BS2 8HW
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Cardiff, South Glamorgan, CF14 4XW
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Edinburgh, Lothian, EH4 2XU
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Harrow, Middlesex, HA1 3UJ
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Liverpool, Merseyside, L7 8XP
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London, Greater London, W12 0HS
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London, WC1E 6AU
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Newcastle upon Tyne, Tyne and Wear, NE1 4LP
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Salford, Greater Manchester, M6 8HD
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Sheffield, S10 2JF
Russia7 sites
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Lipetsk, Russia, 398055
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Moscow, 123154
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Moscow, 129110
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Moskva, Russia, 105203
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Moskva, 127015
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Samara, Russia, 443023
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Volgograd, 400107
Brazil6 sites
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Curitiba, Paraná, 80060-900
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Porto Alegre, Rio Grande do Sul
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Rio de Janeiro, Rio de Janeiro, 21949 900
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Salvador, Estado de Bahia, 40110060
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São Paulo, São Paulo, 05403-900
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São Paulo, São Paulo, 05651-901
Ukraine5 sites
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Donetsk, 83017
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Kharkiv, 61001
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Kiev, 03049
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Lviv, 49044
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Vinnitsa, 26014
New Zealand4 sites
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Auckland, 1023
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Christchurch, 8011
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Hamilton, 3204
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Milford, Auckland, 1309
Switzerland3 sites
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Basel, Basel, 4031
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Bern, Canton of Bern, 3010
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Lausanne, Canton of Vaud, 1011
About this study
Official title: Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Sargramostim (Leukine)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sargramostim (Leukine)Drug
Also called BAY86-5326
Open Label, 8 week cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sargramostim (Leukine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.
Measured: Not applicable for this outcome
Secondary outcomes (3)
Crohn's disease activity
Measured: After successive 8-week cycles of treatment
Duration of clinical remission and time to disease flare
Measured: After successive cycles of sargramostim therapy
Patient compliance
Measured: After successive cycles of sargramostim therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206700
- Sponsor's protocol ID
- 307340
- Other IDs
- 91274, Novel 5
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00206700
- Acronym / sponsor ID
- 307340
- Conditions
- Crohn Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sargramostim (Leukine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sargramostim (Leukine)Also: BAY86-5326Open Label, 8 week cycle | Drug | Arm 1 |
Primary outcome
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
3 secondary outcomes
Crohn's disease activity
Time frame: After successive 8-week cycles of treatment
Duration of clinical remission and time to disease flare
Time frame: After successive cycles of sargramostim therapy
Patient compliance
Time frame: After successive cycles of sargramostim therapy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
167 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sargramostim (Leukine) in people with Crohn Disease, run by Genzyme, a Sanofi Company at 167 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 167 sites in United States, Australia, Canada, United Kingdom, Russia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.