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)

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

Clinical Trial Site

San Giovanni Rotondo, Italy

Clinical Trial Site

Sassari, Italy

Clinical Trial Site

Torino, Italy

View Full Details on ClinicalTrials.gov

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NCT06967480


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