Clinical trial NCT00206700: Open-label Trial of Leukine in Active Crohn's Disease
Official title: Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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 150 points and less than or equal to 450 points) if completely withdrawn from CS use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to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use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)

Primary outcomes:
measure: To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.
timeFrame: Not applicable for this outcome
Secondary outcomes:
measure: Crohn's disease activity
timeFrame: After successive 8-week cycles of treatment
measure: Duration of clinical remission and time to disease flare
timeFrame: After successive cycles of sargramostim therapy
measure: Patient compliance
timeFrame: After successive cycles of sargramostim therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Clearwater
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state: Florida
city: Gainesville
country: United States
state: Florida
city: Gainesville
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state: Florida
city: Hollywood
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state: Florida
city: Jacksonville
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state: Florida
city: Jacksonville
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state: Florida
city: North Miami Beach
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state: Florida
city: Winter Park
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state: Florida
city: Atlanta
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state: Georgia
city: Chicago
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state: Illinois
city: Indianapolis
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state: Indiana
city: Indianapolis
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state: Indiana
city: Lexington
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state: Kentucky
city: Louisville
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state: Kentucky
city: Lake Charles
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state: Louisiana
city: Metairie
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state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Chesterfield
country: United States
state: Michigan
city: Troy
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state: Michigan
city: Plymouth
country: United States
state: Minnesota
city: Mexico
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state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Lincoln
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state: Nebraska
city: Lebanon
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state: New Hampshire
city: Berlin
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Mineola
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city: New York
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city: Rochester
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state: New York
city: Syracuse
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state: New York
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
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state: Ohio
city: Cincinnati
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state: Ohio
city: Oklahoma City
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city: Tulsa
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state: Oklahoma
city: Portland
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state: Oregon
city: Portland
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state: Oregon
city: Portland
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state: Oregon
city: Hanover
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state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sayre
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Memphis
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state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Danville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Seattle
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state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Walla Walla
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Garran
country: Australia
state: Australian Capital Territory
city: Concord
country: Australia
state: New South Wales
city: New Lambton Heights
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Launceston
country: Australia
state: Tasmania
city: Ballarat
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Prahran
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Penrith
country: Australia
city: Salvador
country: Brazil
state: Bahia
city: Curitiba
country: Brazil
state: Parana
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Sao Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Milford
country: New Zealand
state: Auckland
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Lipetsk
country: Russian Federation
state: Russia
city: Moskva
country: Russian Federation
state: Russia
city: Samara
country: Russian Federation
state: Russia
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moskva
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Lausanne
country: Switzerland
state: Waadt
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Bristol
country: United Kingdom
state: Avon
city: London
country: United Kingdom
state: Greater London
city: Salford
country: United Kingdom
state: Greater Manchester
city: Edinburgh
country: United Kingdom
state: Lothian
city: Liverpool
country: United Kingdom
state: Merseyside
city: Harrow
country: United Kingdom
state: Middlesex
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: London
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: