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Efgartigimod for myasthenia gravis in perioperative period: a real-world observational study

Efgartigimod for myasthenia gravis in perioperative period: a real-world observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123395
Enrollment
Unknown
Registered
2026-04-26
Start date
2025-07-09
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Myasthenia gravis

Interventions

Efgartigimod treatment group:None

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of China guidelines for diagnosis and treatment of myasthenia gravis in 2020, and meet the indications of thymectomy; 2. Age >=18 and less than 65; 3. Preoperative preparation with Afgartigimod within 2 months before operation; 4. Serological detection of acetylcholine receptor antibody positive (not limited to methodology); 5. Preoperative mgfa grade 1-4; 6. The dosage of non-hormonal immunosuppressants used in the first three months is stable; 7. No other biological agents and rituximab with the same target were used within six months before operation.

Exclusion criteria

Exclusion criteria: 1. Having undergone any type of thymectomy; 2. IgG<5g/L; 3. Presence of a history of lymphoproliferative disease, active malignancy, or history of active malignancy within the last five years (excluding patients with cervical carcinoma in situ or cutaneous squamous cell carcinoma who received curative resection within three years and have been assessed with no evidence of recurrence);; 4. Suffering from other rheumatic immune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, sarcoidosis, dermatomyositis, spinal arthritis, etc.) and similar diseases; 5. Patients with uncontrolled heart failure, arrhythmias, severe pulmonary hypertension or hypertension, unstable atherosclerotic cardiovascular disease, or other severe cardiovascular diseases, severe gastrointestinal diseases, severe diabetes mellitus, malignant tumors, severe depression, anxiety disorders, or other severe neuropsychiatric conditions, or any other disease that the investigator considers makes the patient unsuitable for participation in the trial; 6. 4 weeks before operation, he was treated with intravenous infusion of high dose methylprednisolone or immunoglobulin.

Design outcomes

Primary

MeasureTime frame
Quantitative Myasthenia Gravis Score;Myasthenia Gravis Activities of Daily Living Score;

Countries

China

Contacts

Public ContactFeng Huiyu

The First Affiliated Hospital, Sun Yat-sen University

fenghuiy@mail.sysu.edu.cn+86 132 4759 4957

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026