Overview
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
Inclusion Criteria:
- 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 Criteria:
- 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