K50
Conditions
Interventions
Group 1: Biomaterials (stool, blood, urine) from Crohn's disease patients are collected with the start of a new biologics therapy. This takes place in week 0 and 16 and thereafter annually.
Sponsors
CED Service GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Crohn's disease Participation in the RUN-CD study Start of a new biologic therapy
Exclusion criteria
Exclusion criteria: Planned surgical intervention Malignant disease in prehistory (without "Non-Melanoma Skin Cancer) Lack of adequate documentation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Survey of the predictive importance of biomarkers for the prediction of side effects and the effectiveness of induction therapy at week 16 and in the long-term, taking into account drug levels / antibodies. 2. Microbiological changes under biologic therapy as a predictor of remission probability and quality of remission | — |
Primary
| Measure | Time frame |
|---|---|
| Frequency of side effects under Biologika Therapy depending on biomarkers for inflammation, genome sequencing, and microbiome changes under therapy at week 16 and in the long term, also taking into account the level of biologics drug levels. | — |
Countries
Germany
Contacts
Public ContactSamantha Fajardo Salmon
CED Service GmbH
Outcome results
None listed