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

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

"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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Jessica Höchstödter; Phone Number: 00494315929574152; Email: j.hoechstoedter@kompetenznetz-ced.de
• Study Contact Backup: Name: Andrea Koch; Phone Number: 00494315929575600; Email: a.koch@kompetenznetz-ced.de

Study Locations

• Germany
  • Niedersachsen
    • Minden, Niedersachsen, Germany, 32423
      • Recruiting
      • Gastroenterologische Gemeinschaftspraxis Minden
      • Contact: Bernd Bokemeyer, PD Dr. med.; Phone Number: +49 571/22567; Email: mailto:bernd.bokemeyer@t-online.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1a; 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; 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; CD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with ≥2 biologic is allowed.	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.
Group 3a; 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; 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; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Measurement of disease activity with HBI	HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events.	Week 0 till year 3
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
Measurement of disease activity with CDAI	CDAI = Crohn's Disease Activity Index	Week 0 till week 16

Collaborators and Investigators

• Sponsor: Ced Service GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Vedolizumab; Infliximab; Ustekinumab
• Other Study ID Numbers: bio101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes