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Effect of urgent intervention by a C5 inhibitor for myasthenia gravis on prognosis (Urgent MG study)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Myasthenia gravis (AChR antibody-positive)
Date of first enrollment	14/05/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, early administration of a C5 inhibitor will be provided to patients with generalized myasthenia gravis, including those who have progressed from ocular to generalized MG. The C5 inhibitor will be initiated within 6 months after the diagnosis of generalization, following the approved dosing regimen used in routine clinical practice.

Outcome(s)

Primary Outcome

Change from baseline in MG-ADL score at 26 weeks

Secondary Outcome

-Change from baseline in MG-ADL score at 14 and 26 weeks -Percentage of responders (reduction of 2 or more points) in MG-ADL score at 14 and 26 weeks -Change from baseline in QMG score at 14 and 26 weeks -Percentage of responders (reduction of 3 or more points) of QMG score at 14 and 26 weeks -Oral steroid withdrawal rate at 14 and 26 weeks -Achievement rate of oral steroids of 5 mg/day or less at 14 and 26 weeks -Achievement rate of oral steroids of 10 mg/day or less at 14 and 26 weeks -Proportion of patients who achieved minimal symptom expression (MSE: MG-ADL score of 0 or 1) by 14 and 26 weeks

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1)Patients aged 18 years or older with AChR antibody-positive myasthenia gravis (MGFA classification: class II to IVb), as per the Myasthenia Gravis Treatment Guidelines (2)Patients diagnosed with generalized MG (gMG) within the past 6 months (Including patients who have transferred from ocular MG to gMG) (3)Patients with an MG-ADL scale score of >=5 (4)Patients weighing >=40 kg after obtaining consent and subtracting 1 kg for the weight of clothing from the weight while clothed. (5)Patients who can provide written informed consent
Exclude criteria	(1)Patients requiring intubation (2)Patients with malignant diseases requiring treatment (3)Patients with meningococcal disease (4)Patients with a history of meningococcal infection, and patients with a history of gonococcal infection. (5)Patients with difficulties in providing informed consent (6)Patients with a history of hypersensitivity to the ingredients of ravulizumab (7)Pregnant women and nursing mothers (8)Patients deemed unsuitable for the study by the principal investigator or similar authority (9)Patients with a history of treatment with C5 inhibitors or FcRn agents