EFG vs IVIG in TAMG

Fudan University

Status and phase

Not yet enrolling

Phase 3

Conditions

Efgartigimod

Intravenous Immunoglobulin

Myasthenia Gravis Associated With Thymoma

Treatments

Combination Product: Efgartigimod + Thymectomy

Combination Product: Intravenous immunglobulin + Thymectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07231523

PROMISE-TAMG

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;