Selective depletion of C-reactive protein by therapeutic apheresis (CRP apheresis) in Crohn's disease and ulcerative colitis
Not Applicable
Recruiting
- Conditions
- K50K51Crohn disease [regional enteritis]Ulcerative colitis
- Registration Number
- DRKS00015460
- Lead Sponsor
- Pentracor GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
Age < 18 = 65 years, Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C), abscesses, blind fistulas, Known hypersensitivity to therapeutic apheresis, pregnancy or lactation, Participation in other interventional tests, Dialysis-liable renal failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br>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.