Study for the Treatment of Ulcerative Colitis With Adacolumn

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