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
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