Clinical trial NCT03108326: Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease
Official title: Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Ced Service GmbH
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
timeFrame: Week 0 till 16
Secondary outcomes:
measure: Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
timeFrame: Week 0 till 8
measure: Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
timeFrame: Week 0 till year 3
measure: Effectiveness of Ustekinumab in different subpopulations
timeFrame: Week 0 till year 3
measure: Measurement of disease activity with HBI
timeFrame: Week 0 till year 3
measure: Measurement of Quality of Life with EQ-5D questionnaire
timeFrame: Week 0 till year 3
measure: Measurement of disease activity with CDAI
timeFrame: Week 0 till week 16
Other outcomes:
Locations:
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
state: Niedersachsen
Study officials:
References: