Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease
NCT ID: NCT03108326
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2017-04-15
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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
No interventions assigned to this group
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.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Ced Service GmbH
OTHER
Responsible Party
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Locations
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Gastroenterologische Gemeinschaftspraxis Minden
Minden, Lower Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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bio101
Identifier Type: -
Identifier Source: org_study_id
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