Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease (RUN-CD)

CED Service GmbH

Status: Unknown

Conditions: Crohn Disease

Treatments: Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra

Study type: Observational

Funder types: Other

Identifiers

NCT03108326

bio101

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

900 participants in 6 patient groups

Group 1a

Description:

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

Description:

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

Description:

CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with ≥2 biologic is allowed.

Treatment:

Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra

Group 3a

Description:

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

Description:

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

Description:

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.

Treatment:

Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra