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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Ravulizumab
  Participants will receive Ravulizumab.

Первичные конечные точки

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

Вторичные конечные точки (12)

• MG-ADL Total Score at Weeks 2, 10, and 26 [Срок оценки: Weeks 2, 10, and 26]
• Change From Baseline in MG-ADL Total Score at Weeks 2, 10 and 26 [Срок оценки: 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 [Срок оценки: Baseline, Weeks 2, 10, 26, and 50]
• Quantitative Myasthenia Gravis (QMG) Total Score at Weeks 2, 10, 26, and 50 [Срок оценки: Weeks 2, 10, 26, and 50]
• Change From Baseline in QMG Total Score at Weeks 2, 10, 26 and 50 [Срок оценки: 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 [Срок оценки: Baseline, Weeks 2, 10, 26, and 50]
• Myasthenia Gravis Composite (MGC) Total Score at Weeks 2, 10, 26, and 50 [Срок оценки: Weeks 2, 10, 26, and 50]
• Change From Baseline in MGC Total Score at Weeks 2,10, 26 and 50 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Weeks 10, 26, and 50]
• Change From Baseline in MG-QoL15r Total Score at Weeks 10, 26 and 50 [Срок оценки: Baseline, Weeks 10, 26 and 50]
• Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 10, 26, and 50 [Срок оценки: Weeks 10, 26, and 50]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 23 центра

• Clinical Trial Site — Bergamo
• Clinical Trial Site — Bologna
• Clinical Trial Site — Bologna
• Clinical Trial Site — Brescia
• Clinical Trial Site — Florence
• Clinical Trial Site — Imperia
• Clinical Trial Site — Lecco
• Clinical Trial Site — Messina
• … и ещё 15 центров

Идентификаторы

NCT: NCT06967480 · D9281R00002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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