Vasculitis
Conditions
Interventions
Group 1: Patients with newly diagnosed vasculitis or patients undergoing a treatment regimen change due to relapse are included if they meet one of the following definitions of vasculitis:
- accordin
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with newly diagnosed vasculitis, whose diagnosis has been established not longer than 6 months prior to the first study visit and informed consent, or patients undergoing a treatment regimen change due to relapse may be included in the study. The diagnosis must be established according to one of the following definitions of vasculitis: - CHCC (Chapel Hill Consensus Conference) nomenclature - ACR (American College of Rheumatology) classification criteria - clinical surrogate markers as specified by the EMA algorithm if histologic confirmation of the diagnosis cannot be achieved - for patients with eosinophilic granulomatosis with polyangiitis according to MIRRA criteria
Exclusion criteria
Exclusion criteria: Patients who are less than 18 yrs old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Included patients will be assessed at eight points over a period of 36 months with respect to the following outcome parameters: - Demography / Consent - Initial Manifestation / Relapse / Change of Treatment Regimen - Comorbidity upon initial manifestation and in the course of disease progression - Vasculitis entity and formal diagnosis - Disease activity - Clinical manifestations - Laboratory tests - Dialysis yes / no - Treatment and Responsiveness to immunosuppressive therapy - Frequency of infectious complications - Treatment side effects (Adverse Drug Reactions) - Malignancy yes/no - Pregnancy yes/no - Overall survival - VDI (Vasculitis Damage Index) Score - BVAS (Birmingham Vasculitis Activity Score) The parameters are evaluated at the respective study visits by means of a web-based platform (electronic case report form, eCRF). VDI and BVAS are assessed as described and validated in the literature. | — |
Secondary
| Measure | Time frame |
|---|---|
| Due to the observational, exploratory study design of the study, no specific distinction is made between primary and secondary outcomes. | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactChristof;Peter Iking-Konert;Lamprecht
Universitätsklinikum Hamburg-Eppendorf III. Medizinische Klinik und Poliklinik Geb. O10;Universitätsklinikum Schleswig-Holstein Campus Lübeck Klinik für Rheumatologie
Outcome results
None listed