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

• Conditions: Crohn Disease
• Interventions: Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra

• Registration Number: NCT03108326
• Lead Sponsor: Ced Service GmbH

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-04-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra	CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with ≥2 biologic is allowed.
Group 4	Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra	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.

Primary Outcome Measures

Name	Time	Method
Effectiveness of induction therapy in CD-patients treated with Ustekinumab.	Week 0 till 16	clinical remission HBI ≤ 4 at week 16

Secondary Outcome Measures

Name	Time	Method
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
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.
Measurement of disease activity with HBI	Week 0 till year 3	HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events.
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

Trial Locations

Locations (1)

Gastroenterologische Gemeinschaftspraxis Minden; 🇩🇪 Minden, Niedersachsen, Germany