Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
NCT ID: NCT06967480
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-07-31
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ravulizumab
Participants will receive Ravulizumab until Week 50 ± 14 days after baseline or until discontinuation.
Ravulizumab
Participants will receive Ravulizumab.
Interventions
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Ravulizumab
Participants will receive Ravulizumab.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , Italy
Clinical Trial Site
Novara, , Italy
Clinical Trial Site
Orbassano, , Italy
Clinical Trial Site
Padua, , 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
Countries
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Central Contacts
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Other Identifiers
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D9281R00002
Identifier Type: -
Identifier Source: org_study_id
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