K50.9 K51.9
Conditions
Interventions
Group 1: Crohn's patients with induction of a biological therapy will be assessed using MSOT and bowel ultrasound.
Group 2: Ulcerative Colitis patients with induction of a biological therapy will be a
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histological verified Crohn’s disease or ulcerative colitis • Age > 18 years • Initiation of a therapy with a biological therapeutic including or current remission o Infliximab and biosimilars o Adalimumab and biosimilars o Golimumab (only ulcerative colitis) o Vedolizumab o Ustekinumab (only Crohn’s disease) o Tofacintinib (only ulcerative colitis)
Exclusion criteria
Exclusion criteria: • age < 18 years • Mental retardation of the patient with restriction of general judgment and awareness • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of MSOT Parameters, ultrasound Parameters and blood tests between responders and non-responders at 0, 2, 6, 12 and 24 (+/- 2) weeks after therapy induction in patients with Crohn’s disease or ulcerative colitis treated with the same biological therapeutic. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Difference of MSOT parameters between various time points (0, 2, 6, 12 and 24 (+/- 2) weeks) after initiation of a new therapy • Difference of MSOT parameters between various therapeutics • Difference of MSOT parameters between patients with active disease under new therapy and patients in remission • Difference of MSOT parameters between Crohn’s disease and ulcerative colitis • Comparison of MSOT results with conventional ultrasound • Comparison of MSOT results with blood tests | — |
Countries
Germany
Contacts
Public ContactDaniel Klett
Medizinische Klinik 1 University of Erlangen-Nürnberg
Outcome results
None listed