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

Effect of early intervention with C5 inhibitors on the prognosis of myasthenia gravis (Urgent MG study) Multicenter prospective study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071260022

Enrollment

Registered

2026-05-14

Start date

2026-05-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis (AChR antibody-positive) MG,Myasthenia gravis,AChR-positive MG

Interventions

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 inhibit

C000629409

C5 inhibitor,Complement inhibition,Ravulizumab,Early intervention,Therapeutic intervention,Treatment for generalized MG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in MG-ADL score at 26 weeks	—

Secondary

Measure	Time frame
-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	—

Measure

Time frame

-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

—

Contacts

Public ContactAkira Tsujino

Nagasaki University Hospital

akrtjn@nagasaki-u.ac.jp+81-95-819-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026