RecruitingNCT06967480
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis
Sponsor
Alexion Pharmaceuticals, Inc.
Enrollment
40 participants
Start Date
Jul 31, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- Diagnosis of MG confirmed by:
- History of a positive serologic test for anti-AChR antibodies, and
- One of the following:
- History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
- History of positive anticholinesterase test (e.g., edrophonium chloride test); or
- Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
- Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
- MGFA class IIb to IV;
- Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
- Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Exclusion Criteria11
- Patient unable to understand and sign the informed consent
- Hypersensitivity to the active substance or to any of the excipients of the study product
- Patient for whom the study product is contraindicated according to SmPC
- Previous treatment with C5 inhibitors
- Last rituximab infusion performed \< 6 months before T-4 (Enrolment)
- Last infusion with FcRn blockers performed \< 3 months before T-4 (Enrollment)
- Pregnant or lactating or planning a pregnancy during the study
- Patient who plan to relocate during the study
- Patient who are unsure of following the visit schedule
- Patient unable to complete questionnaires
- Previous or current participation to other interventional studies
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Interventions
DRUGRavulizumab
Participants will receive Ravulizumab.
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06967480
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