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Completed
NCT07591753
Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)
Conditions: Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 591
Sponsor: European EGPA Study Group
Location: University of Florence Florence Florence
Summary
This observational study aims to evaluate the long-term effectiveness and safety of mepolizumab 300 mg/4 weeks in adults with eosinophilic granulomatosis with polyangiitis (EGPA) in the European real-life setting.
The main questions it aims to answer are:
* How effective is mepolizumab 300 mg/4 weeks over long-term follow-up in patients with EGPA?
* How safe is mepolizumab 300 mg/4 weeks during long-term treatment?
* What are the effects of switching mepolizumab dosage from 300 mg/4 weeks to 100 mg/4 weeks, or from 100 mg/4 weeks to 300 mg/4 weeks?
Participants already receiving mepolizumab as part of routine clinical practice. Researchers will retrospectively collect demographic, clinical, laboratory, and treatment-related data from medical records. For patients starting mepolizumab 300 mg/4 weeks, data will be collected from treatment initiation and during follow-up up to 60 months. For patients who change mepolizumab dose, data will also be collected at the time of dose switch and 3 months later.
Eligibility Criteria
Inclusion Criteria:
* Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Patients who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) Classification Criteria for EGPA or the criteria proposed in the MIRRA trial.
* Patients receiving mepolizumab 300 mg/4 weeks, either as the first mepolizumab regimen or after dose escalation from mepolizumab 100 mg/4 weeks.
* Availability of at least 3 months of follow-up data after mepolizumab initiation or after dose switch.
* Written informed consent.
Exclusion Criteria:
\- Follow-up shorter than 3 months after mepolizumab initiation or after dose switch.
Source: ClinicalTrials.gov (NCT07591753). StuddyBuddy aggregates publicly available trial information.