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.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Device: Adacolumn Apheresis System	Phase III

Further Study Details: 

Primary Outcomes: 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
Expected Total Enrollment:  168

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 (balsalazid 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)

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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
• 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

Robarts Clinical Trials      1-866-560-5828    adacolumn@robarts.ca

California
      University of California, San Francisco, San Francisco,  California,  94143-1623,  United States; Recruiting
Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  30342,  United States; Recruiting
Illinois
      University of Chicago, Department of Medicine, Section of Gastroenterology, Chicago,  Illinois,  60637-1436,  United States; Recruiting
Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, GI Unit, Boston,  Massachusetts,  02114,  United States; Recruiting
      Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center, Boston,  Massachusetts,  02135,  United States; Recruiting
New York
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
      University of North Carolina, Division of Digestive Disease & Nutrition, Chapel Hill,  North Carolina,  27599-7080,  United States; Recruiting
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Cleveland Clinic Fouondation, Cleveland,  Ohio,  44195,  United States; Recruiting
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0632,  United States; Recruiting
      University of Texas Southern Medical Center, Dallas,  Texas,  75390-9016,  United States; Recruiting
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195,  United States; Recruiting
Wisconsin
      University of Wisconsin-Madison, Madison,  Wisconsin,  53792-5124,  United States; Recruiting
Canada, Alberta
      Walter Mackenzie Health Sciences Centre, Edomonton,  Alberta,  T6G 2C8,  Canada; Recruiting
Canada, British Columbia
      Gastroenterology and Hepatology Clinic, Abbotsford,  British Columbia,  V2S 3N5,  Canada; Recruiting
      St Paul’s Hospital, University of British Columbia, Vancouver,  British Columbia,  V6Z 1Y6,  Canada; Recruiting
Canada, Ontario
      London Health Sciences Centre, University Campus, London,  Ontario,  N6A 5A5,  Canada; Recruiting
      London Health Sciences Centre, South Street Campus, London,  Ontario,  N6A 4G5,  Canada; Recruiting
      The Ottawa Hospital-Civic Campus, Ottawa,  Ontario,  K1Y 4E9,  Canada; Recruiting
Canada, Quebec
      Sir Mortimer B. Davis Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
      Hôtel-Dieu de Lévis, Lévis,  Quebec,  G6V 3W6,  Canada; Recruiting

Study ID Numbers:  512-04-205
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  January 24, 2005
ClinicalTrials.gov Identifier:  NCT00102193
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08