Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
NCT ID: NCT03375424
Last Updated: 2017-12-18
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
2500 participants
OBSERVATIONAL
2017-10-02
2024-04-30
Brief Summary
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Detailed Description
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Inclusion Criteria:
* IBD-patients (UC/CD) aged 18-80 years at enrollment
* Written informed consent is given Exclusion Criteria:Lack of adequate documentation possibilities
* Malignant disease in history
* Planned surgical intervention
There are three subpopulations:
1. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
2. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
3. IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed \< 2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Patients with IBD on Vedolizumab/anti-TNF will be documented in a prospective online documentation form at the participating study sites. In parallel, these sites will also document consecutively early disease IBD patients who were diagnosed less than 2 years previously. These patients will be used as a control group.The data will be documented in an online documentation form. After initial documentation at enrollment and during induction (0, 2, 6 and 14 weeks), follow-up documentation using an abbreviated online follow-up form will be requested every 6 months during the longitudinal investigation. Any drug side effects are also captured online on a side effects form.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1st subpopulation
IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
vedolizumab
duration of disease and kind of therapy
2nd subpopulation
IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
No interventions assigned to this group
3rd subpopulation
IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed \<2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
No interventions assigned to this group
Interventions
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vedolizumab
duration of disease and kind of therapy
Eligibility Criteria
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Inclusion Criteria
* Written informed consent is given
Exclusion Criteria
* Malignant disease in history
* Planned surgical intervention
18 Years
80 Years
ALL
No
Sponsors
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Ced Service GmbH
OTHER
Responsible Party
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Principal Investigators
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Bernd Bokemeyer, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden
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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Bernd Bokemeyer, PD Dr. med.
Role: primary
Other Identifiers
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Version 1.4
Identifier Type: -
Identifier Source: org_study_id