Recruiting NCT06967480

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

— Observational Generalized Myasthenia Gravis Anti-AChR Antibody Positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ravulizumab.
Who it may be relevant to: Registry conditions: Generalized Myasthenia Gravis, Anti-AChR Antibody Positive. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis

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

Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50 [Time frame: Week 50]
Change From Baseline in MG-ADL Total Score at Week 50 [Time frame: Baseline, Week 50]

Secondary outcome measures (12)

MG-ADL Total Score at Weeks 2, 10, and 26 [Time frame: Weeks 2, 10, and 26]
Change From Baseline in MG-ADL Total Score at Weeks 2, 10 and 26 [Time frame: Baseline, Weeks 2, 10 and 26]
Percentage of Participants With >=2- Point Reduction From Baseline in MG-ADL Total Score at Weeks 2, 10, 26, and 50 [Time frame: Baseline, Weeks 2, 10, 26, and 50]
Quantitative Myasthenia Gravis (QMG) Total Score at Weeks 2, 10, 26, and 50 [Time frame: Weeks 2, 10, 26, and 50]
Change From Baseline in QMG Total Score at Weeks 2, 10, 26 and 50 [Time frame: Baseline, Weeks 2, 10, 26 and 50]
Percentage of Participants With >=3- Point Reduction From Baseline in QMG Total Score at Weeks 2, 10, 26, and 50 [Time frame: Baseline, Weeks 2, 10, 26, and 50]
Myasthenia Gravis Composite (MGC) Total Score at Weeks 2, 10, 26, and 50 [Time frame: Weeks 2, 10, 26, and 50]
Change From Baseline in MGC Total Score at Weeks 2,10, 26 and 50 [Time frame: Baseline, Weeks 2, 10, 26 and 50]
Percentage of Participants With >=3- Point Reduction From Baseline in MGC Total Score at Weeks 2, 10, 26 and 50 [Time frame: Baseline, Weeks 2, 10, 26, and 50]
Myasthenia Gravis Quality of Life 15-Item Scale - Revised (MG-QoL15r) Total Score at Weeks 10, 26, and 50 [Time frame: Weeks 10, 26, and 50]
Change From Baseline in MG-QoL15r Total Score at Weeks 10, 26 and 50 [Time frame: Baseline, Weeks 10, 26 and 50]
Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 10, 26, and 50 [Time frame: Weeks 10, 26, and 50]

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Italy · 23 centers

NCT: NCT06967480 · D9281R00002