Refractory, chronic active ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
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)
Sponsors
Asahi Kasei Medical Europe GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Exclusion criteria added as of 8 June 2007: 1. Age twice the normal value) 8. Chronic hypotension (80 mmHg or lower systolic) 9. Therapeutic anticoagulation (Cumarine) or coagulation disorder 10. Active bacterial or viral infection, especially acute or chronic Hepatitis B or C virus infection, or HIV infection 11. Severe cardiovascular disease (New York Heart Association [NYHA] III-IV or Canadian Cardiovascular Society [CCS] III-IV), which would not permit any extracorporeal treatment 12. Breast feeding, pregnancy, drug abuse or dementia 13. Participation in another clinical study in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed