EFG vs IVIG in TAMG

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Efgartigimod + Thymectomy
  • Intravenous immunglobulin + Thymectomy

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Tang-Du Hospital

Collaborator

West China Hospital

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

Huashan Hospital

Collaborator

The Affiliated Brain Hospital of Nanjing Medical University

Collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Collaborator

Wuhan TongJi Hospital

Collaborator