K50 K51
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Crohn's disease/ulcerative colitis with active but stable manifestations; Crohn's disease: CDAI 200 - 450 (Crohn's disease activity index); Ulcerative colitis: Mayo score 3-12; Crohn's disease manifestation: Colon and/or small intestine (endoscopic evidence); Ulcerative colitis manifestation: at least rectosigmoiditis; Stable therapy and medication within the previous 4 weeks
Exclusion criteria
Exclusion criteria: Age 38.0 °C), abscesses, blind fistulas, Known hypersensitivity to therapeutic apheresis, pregnancy or lactation, Participation in other interventional tests, Dialysis-liable renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma CRP concentration is determined before and after each apheresis (maximum 9 treatments) plus 2 control measurements each in the 4th and 8th week of treatment and 12 weeks after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of CRP apheresis in the treatment of chronic inflammatory bowel disease (incidence of adverse effects of CRP apheresis), calprotectin concentration in stool, Crohn's disease activity index (CDAI)/Mayo score, Limberg score and „Short Inflammatory Bowel Disease Questionnaire“. The corresponding parameters are determined before the start of the apheresis treatments, as well as 4., 8. and 12. weeks after the start of treatment. | — |
Countries
Germany
Contacts
Pentracor GmbH