Crohn DiseaseRUN-CDNCT03108326
Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease
An observational study of Crohn Disease, run by Ced Service GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2017to 31 Mar 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- CD-patients aged 18-80 years at enrollment written informed consent is given
Who cannot join
- planned surgical intervention malignant disease in history lack of adequate documentation possibilities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Lower Saxony, 32423
Bernd Bokemeyer, PD Dr. med., +49 571/22567, mailto:bernd.bokemeyer@t-online.de
About this study
Official title: 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.
Read the 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:
- Confounding by indication will be taken into account
- Patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account
- The possible influence of co-medication will be considered
- Changing risks over time will be considered
- Power considerations needs to be conducted prior to the comparison of incidence rates
- 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.
- Conditions
- Crohn Disease
- Being tested
- Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraBiological
The data of Crohn´s Disease (CD)-patients on Ustekinumab will be compared in an explorative analysis with CD-patients on other Biologics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra | |
| 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. Receives: Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
clinical remission HBI ≤ 4 at week 16
Measured: Week 0 till 16
Secondary outcomes (6)
Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
clinical remission HBI ≤ 4 at week 8
Measured: 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
Measured: 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.
Measured: Week 0 till year 3
Measurement of disease activity with HBI
HBI= Harvey-Bradshaw-Index (e.g. steroids), co-morbidities and adverse events.
Measured: 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
Measured: Week 0 till year 3
Measurement of disease activity with CDAI
CDAI = Crohn's Disease Activity Index
Measured: Week 0 till week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start15 Apr 2017
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ced Service GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108326
- Sponsor's protocol ID
- bio101
- Acronym
- RUN-CD
- Status last verified
- Jul 2018
- First submitted
- 30 Mar 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome
- ClinicalTrials.gov ID
- NCT03108326
- Acronym / sponsor ID
- RUN-CD / bio101
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ced Service GmbHUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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:
- Confounding by indication will be taken into account
- Patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account
- The possible influence of co-medication will be considered
- Changing risks over time will be considered
- Power considerations needs to be conducted prior to the comparison of incidence rates
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraCD-patients (age at enrollment: 18-80 years) receiving a newly introduced Ustekinumab therapy (n=150). A prior therapy with ≥2 biologic is allowed. |
| 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 | – | Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraCD-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- CD-patients aged 18-80 years at enrollment written informed consent is given
Key exclusion criteria (1 listed)
- planned surgical intervention malignant disease in history lack of adequate documentation possibilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraThe data of Crohn´s Disease (CD)-patients on Ustekinumab will be compared in an explorative analysis with CD-patients on other Biologics. | Biological | Group 2, Group 4 |
Primary outcome
Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
Time frame: Week 0 till 16
clinical remission HBI ≤ 4 at week 16
6 secondary outcomes
Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
Time frame: 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
Effectiveness of Ustekinumab in different subpopulations
Time frame: Week 0 till year 3
Measurement of disease activity with HBI
Time frame: Week 0 till year 3
Measurement of Quality of Life with EQ-5D questionnaire
Time frame: Week 0 till year 3
Measurement of disease activity with CDAI
Time frame: Week 0 till week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Ced Service GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Höchstödter (00494315929574152, j.hoechstoedter@kompetenznetz-ced.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of induction therapy in CD-patients treated with Ustekinumab. (time frame: Week 0 till 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.