Study for the Treatment of Ulcerative Colitis With Adacolumn
A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Ulcerative Colitis
1 other identifier
interventional
168
2 countries
37
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2004
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 24, 2005
CompletedFirst Posted
Study publicly available on registry
January 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedSeptember 8, 2008
April 1, 2008
2 years
January 24, 2005
September 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
Safety will be evaluated by determining the frequency and severity of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
- Adequate peripheral venous access to allow for completion of the apheresis treatments
- Receiving one or more of the following medical therapies:
- \*sulfasalazine, \*mesalamine and other 5-ASA agents, \*prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response
- 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
You may not qualify if:
- Evidence of toxic megacolon
- Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
- Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
- 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
- Insulin-dependent Type I or Type II diabetes
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054, United States
Providence Clinical Research
Burbank, California, 91505, United States
University of California, San Francisco
San Francisco, California, 94143-1623, United States
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, 80033, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Chicago, Department of Medicine, Section of Gastroenterology
Chicago, Illinois, 60637-1436, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital, GI Unit
Boston, Massachusetts, 02114, United States
Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48047, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
University of North Carolina, Division of Digestive Disease & Nutrition
Chapel Hill, North Carolina, 27599-7080, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Digestive Disease Specialists Inc.
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2285, United States
University of Texas Southern Medical Center
Dallas, Texas, 75390-9016, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0632, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792-5124, United States
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2C8, Canada
Gastroenterology and Hepatology Clinic
Abbotsford, British Columbia, V2S 3N5, Canada
St Paul's Hospital, University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
Hotel-Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
London Health Sciences Centre, South Street Campus
London, Ontario, N6A 4G5, Canada
London Health Sciences Centre, University Campus
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital-Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3W6, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yosuke Komatsu, MD, PhD
Otsuka America Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2005
First Posted
January 25, 2005
Study Start
July 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
September 8, 2008
Record last verified: 2008-04