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 Features: * Non-drug therapy * Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
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
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Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Providence Clinical Research
Burbank, California, United States
University of California, San Francisco
San Francisco, California, United States
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago, Department of Medicine, Section of Gastroenterology
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
Massachusetts General Hospital, GI Unit
Boston, Massachusetts, United States
...and 27 more locations