Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease

Crohn Disease Clinical Trial

— RUN-CD  

Official title:

Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108326
• Other study ID #: bio101
• Status: Recruiting
• Start date: April 15, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2018
• Source: Ced Service GmbH
• Contact: Jessica Höchstödter
• Phone: 00494315929574152
• Email: j.hoechstoedter[@]kompetenznetz-ced.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Stelara, 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.

Locations

Country	Name	City	State
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Ced Service GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of induction therapy in CD-patients treated with Ustekinumab.	clinical remission HBI = 4 at week 16	Week 0 till 16
Secondary	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
Secondary	Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.	clinical remission HBI = 4 at year 3	Week 0 till year 3
Secondary	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
Secondary	Measurement of disease activity with HBI	HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events.	Week 0 till year 3
Secondary	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
Secondary	Measurement of disease activity with CDAI	CDAI = Crohn's Disease Activity Index	Week 0 till week 16