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Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

Recruitingn/aAges 18 Years - anyAllAlexion Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Ravulizumab
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Where

23 sites
Clinical Trial Site
Bergamo, Italy
Clinical Trial Site
Bologna, Italy
Clinical Trial Site
Bologna, Italy
Clinical Trial Site
Brescia, Italy
Clinical Trial Site
Florence, Italy
Clinical Trial Site
Imperia, Italy
Clinical Trial Site
Lecco, Italy
Clinical Trial Site
Messina, Italy

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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