Crohn Disease
Conditions
Brief summary
RUN-CD is an investigator initiated Non interventional Trial on biologics in Crohn´s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of Ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.
Detailed description
The effectiveness and safety of induction and maintenance therapy of Ustekinumab and other biologics will be assessed in different relevant subgroups of Crohn's Disease patients. To this end, different confounders have to be considered. Patients followed-up for several years will likely receive changing treatments. These changes have to be taken into account. Furthermore, the decision to prescribe, to stop or to continue a treatment depends on the availability of treatment options and experiences with these alternatives: 1. Confounding by indication will be taken into account 2. Patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account 3. The possible influence of co-medication will be considered 4. Changing risks over time will be considered 5. Power considerations needs to be conducted prior to the comparison of incidence rates 6. Appropriate statistical methods will be applied to deal with these challenges The principles described above will be followed in a similar manner for the analysis of effectiveness and safety endpoints. An appropriate power analysis will be performed before each sub-analysis.
Interventions
BIOLOGICALStelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra
The data of Crohn´s Disease (CD)-patients on Ustekinumab will be compared in an explorative analysis with CD-patients on other Biologics.
Sponsors
Ced Service GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
CD-patients aged 18-80 years at enrollment written informed consent is given
Exclusion criteria
planned surgical intervention malignant disease in history lack of adequate documentation possibilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of induction therapy in CD-patients treated with Ustekinumab. | Week 0 till 16 | clinical remission HBI ≤ 4 at week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. | Week 0 till year 3 | clinical remission HBI ≤ 4 at year 3 |
| Effectiveness of Ustekinumab in different subpopulations | Week 0 till year 3 | e.g. based on prior biologics therapy or clinical parameters/phenotype at baseline in comparison with the other biologics-group. or clinical parameters/phenotype at baseline in comparison with the other biologics-group. |
| Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. | Week 0 till 8 | clinical remission HBI ≤ 4 at week 8 |
| Measurement of Quality of Life with EQ-5D questionnaire | Week 0 till year 3 | EQ-5D™ is a standardised instrument for use as a measure of health outcome |
| Measurement of disease activity with CDAI | Week 0 till week 16 | CDAI = Crohn's Disease Activity Index |
| Measurement of disease activity with HBI | Week 0 till year 3 | HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events. |
Countries
Germany
Contacts
Primary ContactJessica Höchstödter
Backup ContactAndrea Koch
Outcome results
None listed