Study for the Treatment of Crohn's Disease With Adacolumn

Key Inclusion Criteria:

• Moderate to severe Crohn's disease

• 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 healthinformation

Key Exclusion Criteria:

• Extremely severe Crohn's disease

• 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 orintolerance 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 otherthan 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 theinvestigational study

• Used within the last 30 days, an investigational drug, biologic or device or 5half-lives, if known, for any investigational drug or biologic