Adacolumn in Refractory UC Patients Trial

Inclusion criteria

• Patients enrolled into the study will be between 18 and 75 years old and have moderate to severe, steroid-dependent, active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology. Patients will have an ulcerative colitis clinical activity (CAI) of ≥6 and an endoscopic activity index (EAI) of ≥4. Patients will have an insufficient response or intolerance to immunosuppressants and/or biological treatment agents. Patients are required to have adequate peripheral venous access to allow completion of apheresis treatment.

Exclusion criteria

• A patient will be excluded from the study if he/she meets any of the following criteria:

• Is febrile (body temperature >38ºC).
• Has evidence of toxic megacolon.
• Has known obstructive disease of the gastrointestinal system.
• Is anticipated to need surgery within the next 24 weeks.
• Has a history of hypersensitivity reaction associated with an apheresis procedure or an intolerance to apheresis procedures.
• Has proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
• Has a history of allergic reaction to heparin or of heparin-induced thrombocytopenia.
• Has a known infection with enteric pathogens, pathogenic ova or parasites, or a positive test for cytomegalovirus.
• Has symptomatic hypotension.
• Has a history of physical findings consistent with a cerebrovascular accident.
• Has a history of myocardial infarction or unstable angina within the previous 6 months.
• Has undergone coronary artery bypass graft surgery or angioplasty within the previous 6 months.
• Has congestive heart failure (New York Heart Association Class III or IV).
• Has a prosthetic heart valve, pacemaker or other permanent implant.
• Has severe cardiovascular or peripheral vascular disease.
• Has liver disease defined as levels of aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) or alkaline phosphatase of greater than 2.5 × the upper limit of the normal range for the laboratory performing the test.
• Has a history of cirrhosis.
• Has a known bleeding disorder (prothrombin time [PT] or partial thromboplastin time [PTT] greater than 1.5 × the upper limit of the normal range for the laboratory performing the test) or requires concomitant anticoagulant therapy for purposes other than apheresis treatment.
• Has a prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis.
• Has a known infection with hepatitis B or C or human immunodeficiency virus.
• Has abnormal haematology parameters defined as severe anaemia with haemoglobin <8.5 g/dL, white blood cell count <3500/µL or granulocyte count <2000/µL.
• Has a fibrinogen level >700 mg/dL.
• Has renal insufficiency, defined as a serum creatinine level greater than 150% of the upper limit of the normal range for the laboratory performing the test.
• Has had major surgery within the previous 6 weeks.
• Has any of the following types of infection:

• An active infection within 4 weeks of successful completion of antibiotic treatment for a bacterial infection.
• Febrile viral infection within the 4 weeks prior to entry into the study.
• Systemic fungal infection that required therapy which was completed within the 12 weeks prior to entry into the study.
• Current drug or alcohol abuse.
• Is pregnant, lactating or planning to become pregnant during the study.
• Has used an investigational medicinal product, biologic agent or device within the last 30 days.
• Adults lacking capacity who are unable to give consent by themselves due to physical and or mental incapacity.
• Prisoners and patients who have undergone psychiatric treatment.