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Self-management for early detection of vasculitis flare-ups: a prospective study

Self-management for early detection of vasculitis flare-ups: a prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039228
Enrollment
200
Registered
2026-02-13
Start date
2026-02-23
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant cell arteritis, polymyalgia rheumatica, ANCA-associated vasculitides

Interventions

Group 1: Self-management group: digital questionnaires, independent blood sampling, urine measurements, photo/video documentation every 4 weeks, on-site appointments as part of routine care every 3-6

Sponsors

Rheumazentrum Ruhrgebiet, Universitätsklinikum der Ruhr-Universität Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of vasculitis/PMR (ICD-10: M30.1, M31.1, M31.7, M31.5, M31.4, M35.3, M35.3) - Consent of the patient - Patient capable of giving consent

Exclusion criteria

Exclusion criteria: - Failure to meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Number of flares confirmed by rheumatologists between routine appointments

Secondary

MeasureTime frame
- Change in disease damage (VDI - vasculitis damage index) from baseline to end of study - Difference in patient satisfaction at the end of the study? (eZAP, TUUSQ) Exploratory endpoints: - Time (days) from baseline to the first disease activity-driven intensification (escalation) of therapy for the underlying disease - Molecular and cellular biomarkers and cell-cell interactions in the pathogenesis of the disease, with a particular focus on the occurrence of relapses - Differences in the use of medical resources - Rate of disease activity-driven intensification of therapy (escalation) for the underlying disease - Total number of infections requiring antibiotics - Use of medical resources (consultations, outpatient/inpatient appointments) - Adjustment of antidiabetic therapy (newly started/dose increased) - Adjustment of antihypertensive therapy (newly started/dose increased) - Change in cortisone dose from baseline to end of study - Adherence to home monitoring

Countries

Germany

Contacts

Public ContactAnna Kernder

Rheumazentrum Ruhrgebiet, Universitätsklinikum der Ruhr-Universität Bochum

Anna.kernder@elisabethgruppe.de+49 2325 592 131

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026