Study for the Treatment of Crohn's Disease With Adacolumn
NCT ID: NCT00162942
Last Updated: 2009-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2005-01-31
2007-12-31
Brief Summary
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Detailed Description
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* Medical device (Non-drug option)
* Most patients can remain on current treatment regimen throughout the study
Components of the Study:
* Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
* Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
* 2:1 Randomization (treatment:sham)
* Open-Label extension offered to eligible patients
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Adacolumn
Adacolumn, ten apheresis sessions within 9 weeks
Adacolumn
Ten apheresis sessions:
One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
Sham
Sham, ten apheresis sessions within 9 weeks
Sham
Sham, ten apheresis sessions within 9 weeks
Interventions
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Adacolumn
Ten apheresis sessions:
One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
Sham
Sham, ten apheresis sessions within 9 weeks
Eligibility Criteria
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Inclusion Criteria
* Adequate peripheral venous access
* Agree to participate in the required follow-up visits
* Able to complete a diary
* Signed written informed consent document and authorization for use of protected health information
Exclusion Criteria
* Known obstructive symptoms within the past 3 months
* Presence of toxic megacolon
* Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
* Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
* Requiring in-patient hospitalization
* A history of allergic reaction to heparin or heparin-induced thrombocytopenia
* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
* A history of severe cardiovascular or peripheral arterial diseases
* A history of cerebral vascular diseases
* Liver diseases
* Renal insufficiency
* Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
* Any hypercoagulable disorder
* Known infection with Hepatitis B or C, or HIV
* Severe anemia
* Leukopenia or granulocytopenia
* Evidence of current systemic infection
* Malignancy
* Pregnant, lactating or planning to become pregnant during the course of the investigational study
* Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
18 Years
75 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Responsible Party
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Otsuka America Pharmaceutical, Inc
Principal Investigators
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Yosuke Komatsu, MD, PhD
Role: STUDY_DIRECTOR
Otsuka America Pharmaceutical
Locations
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Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Capitol Gastroenterology Consultants Medical Group
Roseville, California, United States
UCSF Mount Zion Medical Center
San Francisco, California, United States
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, United States
Medical Research Institute of Connecticut
Hamden, Connecticut, United States
Venture Research Institute, LLC
North Miami Beach, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
Massachusetts General Hospital, GI Unit
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
University of North Carolina, Division of Digestive Disease & Nutrition
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Madison, Wisconsin, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Gastroenterology & Hematology Clinic
Abbotsford, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Sands BE, Katz S, Wolf DC, Feagan BG, Wang T, Gustofson LM, Wong C, Vandervoort MK, Hanauer S. A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's disease. Gut. 2013 Sep;62(9):1288-94. doi: 10.1136/gutjnl-2011-300995. Epub 2012 Jul 3.
Other Identifiers
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512-04-206
Identifier Type: -
Identifier Source: org_study_id
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