Prospective, monocentric, open, one-arm clinical Phase I/IIa study regarding safety and predictive capacity of two-time topical application of FITC-adalimumab as an in-vivo diagnostic tool in combination with confocal laser endomicroscopy in ulcerative colitis patients with indication for anti-TNF antibody adalimumab therapy
Phase 1
Recruiting
- Conditions
- K51.9Ulcerative colitis, unspecified
- Registration Number
- DRKS00014353
- Lead Sponsor
- Medizinische Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg Dekanat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Patients with moderate-to-sever ulcerative colitis and indication for therapy with the anti-TNF antibody adalimumab
Exclusion Criteria
- Undefined colitis, including differential diagnosis of Crohn's disease, ischemic colitis, infectious colitis.
- Stenosis due to ulcerative colitis
- Fulminat ulcerative colitis
- Toxic megacolon
- Colectomy
- Ileo-anal Pouch or ileo-rectosomie or ileostoma
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of FITC-Adalimumab after two-time topical application on the mucosa of patients with active ulcerative colitis in conjunction with confocal endomicroscopy at week 0 and 9 is the primary endpoint of the study.
- Secondary Outcome Measures
Name Time Method - Capacity of FITC-Adalimumab to visualize mTNF+ cells in vivo during endoscopy at week 0 and 9 is a secondary endpoint of the study.<br><br>- Predictive capacity of molecular endoscopy with FITC-Adalimumab at week 0 and 9 and visualization of mTNF+ cells regarding therapeutic efficacy of subsequent adalimumab therapy in active ulcerative colitis patients at week 9 and day 176 and 372 is a secondary endpoint of the study. Predictive capacity of the number of mTNF+ cells regarding therapeutic efficacy of subsequent anti-TNF Adalimumab therapy.