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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03108326 |
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Date of registration:
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30/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease
RUN-CD |
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Scientific title:
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Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome |
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Date of first enrolment:
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April 15, 2017 |
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Target sample size:
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900 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03108326 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bernd Bokemeyer, PD Dr. med. |
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Address:
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Telephone:
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+49 571/22567 |
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Email:
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mailto:bernd.bokemeyer@t-online.de |
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Affiliation:
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Name:
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Jessica Höchstödter |
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Address:
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Telephone:
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00494315929574152 |
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Email:
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j.hoechstoedter@kompetenznetz-ced.de |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra
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Primary Outcome(s)
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Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
[Time Frame: Week 0 till 16]
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Secondary Outcome(s)
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Measurement of disease activity with CDAI
[Time Frame: Week 0 till week 16]
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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]
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Measurement of disease activity with HBI
[Time Frame: Week 0 till year 3]
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Measurement of Quality of Life with EQ-5D questionnaire
[Time Frame: Week 0 till year 3]
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Effectiveness of Ustekinumab in different subpopulations
[Time Frame: Week 0 till year 3]
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Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.
[Time Frame: Week 0 till 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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