A multicenter, randomized, double-blind, placebo-controlled investigation of long-term safety and efficacy of LCAP (leukocytapheresis using "Cellsorba FX") in patients with refractory, chronic active ulcerative colitis

INTERVENTION: Please note that this study was terminated on 25 April 2007 due to unsatisfactory patient enrolment. Interventions provided at registration: Extracorporeal leukocytapheresis (LCAP; verum group) versus sham‐leukocytaphersis (placebo group) CONDITION: Refractory, chronic active ulcerative colitis ; Digestive System ; Ulcerative colitis PRIMARY OUTCOME: Primary outcome measures added as of 8 June 2007: ; ; The primary efficacy parameter is the 7‐item Clinical Activity Index (CAI). A sum score will be calculated summing up all items that are differently weighted. The range of the sum score is 0 to 29 points. A sum score of less than four (or less than or equal to 4) points at the end of the therapy will be assessed as remission or success. SECONDARY OUTCOME: Secondary outcome measures added as of 8 June 2007: ; ; 1. Inflammatory Bowel Disease Questionnaire (IBDQ), German translation. This questionnaire consists of four domains and 32 items. Domains are simply the sum of specific items, i.e. bowel symptoms, systemic symptoms, emotional functions and social functions.; 2. Endoscopic Index (EI), which includes 4 items with different weights. The range of the sum score is 0 to 12 points.; 3. Cumulative steroid dose over intensive and maintenance phase.; 4. CAI, item‐wise analysis. INCLUSION CRITERIA: 1. Ulcerative colitis with chronic active disease state 2. Colitis endoscopically covering at least 15 cm 3. Clinical Activity Index: 6‐10 4. No long term remission using combined standard therapy including 5‐Aminosalicylate (ASA), prednisolone and/or azathioprine 5. Cumulative steroid dosage within the last 2 months in total at least 600 mg 6. Steroid dosage constant 10 mg per day during 2 weeks before start of treatment (pre‐treatment phase) 7. Negative test of pregnancy for female patients 8. Patient is able to understand and sign informed consent