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"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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with biologics is not allowed. | ||
| Group 1b | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with 1 biologics is allowed | ||
| Group 2 | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with ≥2 biologic is allowed. |
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| Group 3a | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced biologics therapy other than Ustekinumab (n=150). A prior therapy with biologic is not allowed. | ||
| Group 3b | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced biologics therapy other than Ustekinumab (n=150). A prior therapy with 1 biologic is allowed. | ||
| Group 4 | CD-patients (age at enrollment: 18-80 years) receiving a newly introduced biologics therapy other than Ustekinumab (n=150). A prior therapy with ≥2 biologics is allowed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra | Biological | The data of Crohn´s Disease (CD)-patients on Ustekinumab will be compared in an explorative analysis with CD-patients on other Biologics. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of induction therapy in CD-patients treated with Ustekinumab. | clinical remission HBI ≤ 4 at week 16 | Week 0 till 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. | clinical remission HBI ≤ 4 at week 8 | Week 0 till 8 |
| Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. |
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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
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The Crohn´s Disease (CD)-patients will be prospectively documented in the post-marketing observational investigator initiated study (RUN-CD). The diagnosis is made in accordance with current DGVS/ECCO CD-guidelines.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Höchstödter | Contact | 00494315929574152 | j.hoechstoedter@kompetenznetz-ced.de | |
| Andrea Koch | Contact | 00494315929575600 | a.koch@kompetenznetz-ced.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterologische Gemeinschaftspraxis Minden | Recruiting | Minden | Lower Saxony | 32423 | Germany |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| D000069285 | Infliximab |
| C543529 | vedolizumab |
| D000068879 | Adalimumab |
| C000591237 | CT-P13 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
clinical remission HBI ≤ 4 at year 3 |
| Week 0 till year 3 |
| Effectiveness of Ustekinumab in different subpopulations | 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. | Week 0 till year 3 |
| Measurement of disease activity with HBI | HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events. | Week 0 till year 3 |
| Measurement of Quality of Life with EQ-5D questionnaire | EQ-5D™ is a standardised instrument for use as a measure of health outcome | Week 0 till year 3 |
| Measurement of disease activity with CDAI | CDAI = Crohn's Disease Activity Index | Week 0 till week 16 |
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |