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

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ClinicalTrials.gov Identifier: NCT03108326
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ced Service GmbH

Study Description
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Brief 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 favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.

Condition or disease Intervention/treatment
Crohn Disease 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of induction therapy in CD-patients treated with Ustekinumab. [ Time Frame: Week 0 till 16 ]
    clinical remission HBI ≤ 4 at week 16


Secondary Outcome Measures :
  1. 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

  2. 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

  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.


  4. 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.

  5. 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

  6. Measurement of disease activity with CDAI [ Time Frame: Week 0 till week 16 ]
    CDAI = Crohn's Disease Activity Index


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108326


Contacts
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Contact: Jessica Höchstödter 00494315929574152 j.hoechstoedter@kompetenznetz-ced.de
Contact: Andrea Koch 00494315929575600 a.koch@kompetenznetz-ced.de

Locations
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Germany
Gastroenterologische Gemeinschaftspraxis Minden Recruiting
Minden, Niedersachsen, Germany, 32423
Contact: Bernd Bokemeyer, PD Dr. med.    +49 571/22567    mailto:bernd.bokemeyer@t-online.de   
Sponsors and Collaborators
Ced Service GmbH
More Information
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Additional Information:

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Responsible Party: Ced Service GmbH
ClinicalTrials.gov Identifier: NCT03108326    
Other Study ID Numbers: bio101
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Infliximab
Ustekinumab
Vedolizumab
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents