A Study of Abatacept in Patients With Active Crohn's Disease
NCT ID: NCT00406653
Last Updated: 2010-09-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
451 participants
INTERVENTIONAL
2006-12-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
4 arms for induction period
2 arms for maintenance period
abatacept
Dextrose 5% in water, intravenous (IV).
Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
\~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57.
Induction Period 3 months
Maintenance Period 12 months
2
4 arms for induction period
2 arms for maintenance period
placebo
Normal saline, IV, 0 mg/kg, every 28 days.
Induction Period 3 months
Maintenance Period 12 months
abatacept
1 arm for open-label extension phase
abatacept
\~10 mg/kg, every 28 days.
Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued
Interventions
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abatacept
Dextrose 5% in water, intravenous (IV).
Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
\~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57.
Induction Period 3 months
Maintenance Period 12 months
placebo
Normal saline, IV, 0 mg/kg, every 28 days.
Induction Period 3 months
Maintenance Period 12 months
abatacept
\~10 mg/kg, every 28 days.
Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have had Crohn's Disease for at least 3 months
* moderate to severely active Crohn's Disease
* have had an inadequate response or intolerance to other Crohn's Disease treatments
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama Medical Center
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
The Permanente Medical Group, Inc
Sacramento, California, United States
University Of Florida
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Shafran Gasteroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University Of Chicago Hospitals
Chicago, Illinois, United States
Health Science Center
Pratt, Kansas, United States
University Of Kentucky Medical Center
Lexington, Kentucky, United States
University Of Louisville
Louisville, Kentucky, United States
Gulf Coast Research Assoc
Baton Rouge, Louisiana, United States
Vanderlick, Michael
Lafayette, Louisiana, United States
Maryland Digestive Disease Research
Laurel, Maryland, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Kansas City Gastroenterology And Hepatology
Kansas City, Missouri, United States
Aga Clinical Research Associates, Llc
Egg Harbor Twp, New Jersey, United States
Long Island Clinical Research
Great Neck, New York, United States
Mount Sinai School Of Medicine
New York, New York, United States
U Of Rochester Gastroenterology And Hepatology
Rochester, New York, United States
University Endoscopy Center
Syracuse, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Gastroenterology Specialists, Inc.
Canton, Ohio, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
Gastrointestinal & Liver Diseases Consultants
Dayton, Ohio, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Allegheny Center For Digestive Health
Pittsburgh, Pennsylvania, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
Gastroenterology Center Of The Midsouth, P.C.
Germantown, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Nashville Medical Research
Nashville, Tennessee, United States
Austin Gastroenterology, Pa
Austin, Texas, United States
Gastroenterology Clinic Of San Antonio
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Local Institution
Garran, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
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Bedford Park, South Australia, Australia
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Launceston, Tasmania, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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South Ballarat, Victoria, Australia
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Fremantle, Western Australia, Australia
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Bonheiden, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Salvador, Estado de Bahia, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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České Budějovice, , Czechia
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Aalborg, , Denmark
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Arhus C, , Denmark
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Hvidovre, , Denmark
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Odense C, , Denmark
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Amiens, , France
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Lille, , France
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Nice, , France
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Paris, , France
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Pessac, , France
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Toulouse, , France
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Kiel, , Germany
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Münster, , Germany
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Münster, , Germany
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Hyderabad, Andhra Pradesh, India
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Hyderabad, , India
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Mangalore, , India
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Manipal, , India
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Mumbai, , India
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Mysore, , India
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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San Giovanni Rotondo, , Italy
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Torreón, Coahuila, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Rotterdam, , Netherlands
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Katowice, , Poland
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Ponce, , Puerto Rico
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Overport, KwaZulu-Natal, South Africa
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Belville, Western Cape, South Africa
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Bern, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
Countries
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References
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Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.
Other Identifiers
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IM101-084
Identifier Type: -
Identifier Source: org_study_id