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

July 12, 2018 updated by: Ced Service GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Niedersachsen
      • Minden, Niedersachsen, Germany, 32423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
Time Frame: Week 0 till 16
clinical remission HBI ≤ 4 at week 16
Week 0 till 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
Time Frame: Week 0 till 8
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.
Time Frame: Week 0 till year 3
clinical remission HBI ≤ 4 at year 3
Week 0 till year 3
Effectiveness of Ustekinumab in different subpopulations
Time Frame: 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.
Week 0 till year 3
Measurement of disease activity with HBI
Time Frame: Week 0 till year 3
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
Time Frame: Week 0 till year 3
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
Time Frame: Week 0 till week 16
CDAI = Crohn's Disease Activity Index
Week 0 till week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ced Service GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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