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

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

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

Conditions3

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