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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011811

Enrollment

900

Registered

2017-03-06

Start date

2017-04-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50

Interventions

Group 1: CD-patients (age at enrollment: 18-80 years) with initiation of new ustekinumab therapy in biologic-naive patients. The patients are observed within their normal treatment. Three years of dat

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: CD (Crohn´s Disease)-patients aged 18-80 years at enrollment written informed consent is given New beginning biologica therapy

Exclusion criteria

Exclusion criteria: planned surgical intervention malignant disease in history (approved "Non-Melanoma Skin Cancer) lack of adequate documentation possibilities

Design outcomes

Primary

Measure	Time frame
Effectiveness of induction therapy (clinical remission HBI (Harvey-Bradshaw Index for assessment of disease activity) = 4) at week 16 in CD-patients treated with Ustekinumab.	—

Secondary

Measure	Time frame
1.Effectiveness of induction therapy (clinical remission HBI (Harvey-Bradshaw Index for assessment of disease activity) = 4) at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. 2. Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. 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. 4. Identification of baseline predictors for clinical remission in induction and maintenance therapy in a multivariate analysis. 5. Descriptive analysis of disease course (disease activity, phenotype, use of indicator drugs (e.g. steroids), co-morbidities) and adverse events. 6. Generation of health economic and Quality of Life (QoL) data in a half-years rhythm within 3 years (hospitalizations, disability, cost of treatment, quality of life), and to compare groups of patients well-balanced for different parameters (HBI, age, previous therapies) in an additional subanalysis.	—

Measure

Time frame

1.Effectiveness of induction therapy (clinical remission HBI (Harvey-Bradshaw Index for assessment of disease activity) = 4) at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. 2. Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab. 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. 4. Identification of baseline predictors for clinical remission in induction and maintenance therapy in a multivariate analysis. 5. Descriptive analysis of disease course (disease activity, phenotype, use of indicator drugs (e.g. steroids), co-morbidities) and adverse events. 6. Generation of health economic and Quality of Life (QoL) data in a half-years rhythm within 3 years (hospitalizations, disability, cost of treatment, quality of life), and to compare groups of patients well-balanced for different parameters (HBI, age, previous therapies) in an additional subanalysis.

—

Countries

Germany

Contacts

Public ContactSamantha Fajardo Salmon

CED Service GmbH

s.fajardo@kompetenznetz-darmerkrankungen.de+49 (0)251 928 70 533

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026