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NCT Number: NCT07231523

EFG vs IVIG in TAMG

This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged >18 years and ≤75 years, with an expected survival time >12 months;
  • Patients with generalized myasthenia gravis;
  • MG-ADL ≥6;
  • Positive for AChR antibody;
  • Diagnosed with thymoma by enhanced chest CT or MRI;
  • Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;
  • Patients with American Society of Anesthesiologists (ASA) grade 1-2;
  • Able to understand the study situation and sign the Informed Consent.

Exclusion criteria

  • MGFA type V;
  • Patients who have undergone median sternotomy;
  • Confirmed history of congestive heart failure; poorly controlled angina pectoris with drug treatment; electrocardiogram (ECG) confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;
  • Patients with weight loss of more than 5kg in the past month; severe uncontrolled systemic disease, such as active infection or poorly controlled diabetes; patients with hemorrhagic diseases and bleeding tendencies; coagulation dysfunction, bleeding tendency or receiving thrombolytic or anticoagulant therapy; patients with grade II-IV bone marrow suppression;
  • Females with positive serum pregnancy test or in lactation period, and males and females of childbearing age who are unwilling to use adequate contraceptive measures during treatment;
  • History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
  • Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;
  • Patients participating in other clinical studies simultaneously;
  • Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;
  • Patients in the acute inflammatory period due to bacterial, viral or other microbial infections; known active infections of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), or known HIV seropositivity;
  • Patients who have undergone thoracic surgery due to tuberculous pleurisy, mesothelioma, lung disease, or diaphragmatic disease, with ipsilateral lung atelectasis involving one lobe or more than one lobe;
  • Serum IgG level <4.5 g/L;
  • Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
  • Thrombosis, renal impairment or renal failure;
  • Allergic to human immunoglobulin or have other severe allergic history;
  • Selective IgA deficiency with anti-IgA antibodies;
  • Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:

Blood: white blood cells <4.0×10^9/L, absolute neutrophil count (ANC) <2.0×10^9/L, platelet count <100×10^9/L, hemoglobin <90g/L; Liver function: serum bilirubin >1.5 times the upper normal limit; ALT and AST >1.5 times the upper normal limit; Renal function: serum creatinine (SCr) >120 μmol/L, creatinine clearance rate (CCr) <60 ml/min;

Treatment and study plan

Efgartigimod + Thymectomy

Combination Product

Patients receive weight-based EFG infusions (10 mg/kg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.

Intravenous immunglobulin + Thymectomy

Combination Product

Patients receive weight-based IVIG infusions (400 mg/kg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.

Primary outcomes

  1. Quantitative Myasthenia Gravis (QMG) reduction

    Time frame: From baseline to 2 weeks postoperatively

    The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.

Secondary outcomes

  1. Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction

    Time frame: From baseline to 2 weeks postoperatively

    The total MG-ADL score ranges from 0 to 24, with higher scores indicating more severe condition

  2. Myasthenia Gravis Composite (MGC) reduction

    Time frame: From baseline to 2 weeks postoperatively

    The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.

  3. QMG change (1 day preoperatively)

    Time frame: From baseline to 1 day preoperatively

    The change in the QMG score from baseline to 1 day preoperatively

  4. QMG change (1 week postoperatively)

    Time frame: From baseline to 1 week postoperatively

    The change in the QMG score from baseline to 1 week postoperatively

  5. QMG change (1 month postoperatively)

    Time frame: From baseline to 1 month postoperatively

    The change in the QMG score from baseline to 1 month postoperatively

  6. QMG change (2 months postoperatively)

    Time frame: From baseline to 2 months postoperatively

    The change in the QMG score from baseline to 2 months postoperatively

  7. MG-ADL change (1 day preoperatively)

    Time frame: From baseline to 1 day preoperatively

    The change in the MG-ADL score from baseline to 1 day preoperatively

  8. MG-ADL change (1 week postoperatively)

    Time frame: From baseline to 1 week postoperatively

    The change in the MG-ADL score from baseline to 1 week postoperatively

  9. MG-ADL change (1 month postoperatively)

    Time frame: From baseline to 1 month postoperatively

    The change in the MG-ADL score from baseline to 1 month postoperatively

  10. MG-ADL change (2 months postoperatively)

    Time frame: From baseline to 2 months postoperatively

    The change in the MG-ADL score from baseline to 2 months postoperatively

  11. MGC change (1 day preoperatively)

    Time frame: From baseline to 1 day preoperatively

    The change in the MGC score from baseline to 1 day preoperatively

  12. MGC change (1 week postoperatively)

    Time frame: From baseline to 1 week postoperatively

    The change in the MGC score from baseline to 1 week postoperatively

  13. MGC change (1 month postoperatively)

    Time frame: From baseline to 1 month postoperatively

    The change in the MGC score from baseline to 1 month postoperatively

  14. MGC change (2 months postoperatively)

    Time frame: From baseline to 2 months postoperatively

    The change in the MGC score from baseline to 2 months postoperatively

  15. IgG reduction (1 day preoperatively)

    Time frame: From baseline to 1 day preoperatively

    The reduction in the IgG level from baseline to 1 day preoperatively

  16. IgG reduction (1 week postoperatively)

    Time frame: From baseline to 1 week postoperatively

    The reduction in the IgG level from baseline to 1 week postoperatively

  17. IgG reduction (2 weeks postoperatively)

    Time frame: From baseline to 2 weeks postoperatively

    The reduction in the IgG level from baseline to 2 weeks postoperatively

  18. IgG reduction (1 month postoperatively)

    Time frame: From baseline to 1 month postoperatively

    The reduction in the IgG level from baseline to 1 month postoperatively

  19. IgG reduction (2 months postoperatively)

    Time frame: From baseline to 2 months postoperatively

    The reduction in the IgG level from baseline to 2 months postoperatively

  20. AChR-Ab reduction (1 day preoperatively)

    Time frame: From baseline to 1 day preoperatively

    The reduction in the AChR-Ab level from baseline to 1 day preoperatively

  21. AChR-Ab reduction (2 weeks postoperatively)

    Time frame: From baseline to 2 weeks postoperatively

    The reduction in the AChR-Ab level from baseline to 2 weeks postoperatively

  22. AChR-Ab reduction (1 month postoperatively)

    Time frame: From baseline to 1 month postoperatively

    The reduction in the AChR-Ab level from baseline to 1 month postoperatively

  23. Proportion of steroid dose reduction

    Time frame: From baseline to 2 months postoperatively

    The rate of reduction in steroid dose from baseline to 2 months postoperatively

  24. Incidence of myasthenic crisis

    Time frame: Perioperative period

    The incidence of postoperative myasthenia gravis crisis, from the start of the trial to the end of the follow-up period

  25. Incidence of total perioperative complications (≥3)

    Time frame: Perioperative period

    The incidence of total perioperative complications assessed by Clavien-Dindo classification

  26. Incidence of perioperative infection-related complications

    Time frame: Perioperative period

    The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianyong Ding

CONTACT

[email protected]

+86 18616881268

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Huashan Hospital
  • Second Affiliated Hospital of Soochow University
  • Tang-Du Hospital
  • The Affiliated Brain Hospital of Nanjing Medical University
  • The Affiliated Hospital of Xuzhou Medical University
  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Wuhan TongJi Hospital

Registry information

Official study title

Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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