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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Patient unable to understand and sign the willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Ravulizumab

Participants will receive Ravulizumab.

Locations (20)

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
Clinical Trial Site
Milan, Italy
Clinical Trial Site
Milan, Italy
Clinical Trial Site
Naples, Italy
Clinical Trial Site
Novara, Italy
Clinical Trial Site
Orbassano, Italy
Clinical Trial Site
Padova, Italy
Clinical Trial Site
Palermo, Italy
Clinical Trial Site
Parma, Italy
Clinical Trial Site
Pavia, Italy
Clinical Trial Site
Pisa, Italy
Clinical Trial Site
Roma, Italy
Clinical Trial Site
Salerno, Italy