Joint Vasculitis Registry in German-speaking Countries

Recruiting

Conditions: Vasculitis

Registration Number: DRKS00011866

Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Lübeck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

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

Patients who are less than 18 yrs old

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Included patients will be assessed at eight points over a period of 36 months with respect to the following outcome parameters:<br><br>- Demography / Consent<br>- Initial Manifestation / Relapse / Change of Treatment Regimen<br>- Comorbidity upon initial manifestation and in the course of disease progression <br>- Vasculitis entity and formal diagnosis<br>- Disease activity <br>- Clinical manifestations<br>- Laboratory tests<br>- Dialysis yes / no<br>- Treatment and Responsiveness to immunosuppressive therapy<br>- Frequency of infectious complications <br>- Treatment side effects (Adverse Drug Reactions)<br>- Malignancy yes/no<br>- Pregnancy yes/no<br>- Overall survival <br>- VDI (Vasculitis Damage Index) Score<br>- BVAS (Birmingham Vasculitis Activity Score)<br><br>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 Outcome Measures