Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
378 participants
INTERVENTIONAL
2003-02-28
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Sargramostim (Leukine)
Open Label, 8 week cycle
Interventions
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Sargramostim (Leukine)
Open Label, 8 week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 150 points and less than or equal to 450 points) if completely withdrawn from CS use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to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use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
* 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)
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
San Francisco, California, United States
Tarzana, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
North Miami Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Lake Charles, Louisiana, United States
Metairie, Louisiana, United States
Slidell, Louisiana, United States
Annapolis, Maryland, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Chesterfield, Michigan, United States
Troy, Michigan, United States
Plymouth, Minnesota, United States
Mexico, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Lebanon, New Hampshire, United States
Berlin, New Jersey, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Hanover, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sayre, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Bristol, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Danville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Walla Walla, Washington, United States
Wenatchee, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Buenos Aires F.D., Argentina
Garran, Australian Capital Territory, Australia
Concord, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Launceston, Tasmania, Australia
Ballarat, Victoria, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Prahran, Victoria, Australia
Fremantle, Western Australia, Australia
Penrith, , Australia
Salvador, Estado de Bahia, Brazil
Curitiba, Paraná, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Milford, Auckland, New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Lipetsk, Russia, Russia
Moskva, Russia, Russia
Samara, Russia, Russia
Moscow, , Russia
Moscow, , Russia
Moskva, , Russia
Volgograd, , Russia
Basel, Basel, Switzerland
Bern, Canton of Bern, Switzerland
Lausanne, Canton of Vaud, Switzerland
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Vinnitsa, , Ukraine
Bristol, Avon, United Kingdom
London, Greater London, United Kingdom
Salford, Greater Manchester, United Kingdom
Edinburgh, Lothian, United Kingdom
Liverpool, Merseyside, United Kingdom
Harrow, Middlesex, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
London, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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91274
Identifier Type: -
Identifier Source: secondary_id
Novel 5
Identifier Type: -
Identifier Source: secondary_id
307340
Identifier Type: -
Identifier Source: org_study_id
NCT00185471
Identifier Type: -
Identifier Source: nct_alias