Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of efgartigimod followed by telitacicept in patients with generalized myasthenia gravis (gMG). Specifically, the trial seeks to determine the optimal treatment strategy for gMG by assessing the effect of sequential biologic therapy on disease management.
Study Design: This is a multi-center, open-label, randomized controlled trial involving 60 acetylcholine receptor antibody-positive gMG patients.
The patient voluntarily signs the informed consent form.
Age ≥18 and ≤80 years, regardless of gender.
Meets the diagnostic criteria for Myasthenia Gravis (MG) as per the 2020 China MG Diagnosis and Treatment Guidelines, with serological evidence of positive AChR-Ab.
MG Clinical Classification according to the Myasthenia Gravis Foundation of America (MGFA) Staging System: Grade II-IV.
Coexisting active autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Sjögren's Syndrome, etc.
Patients with active infections, such as Herpes Zoster, HIV, active Tuberculosis, active Hepatitis.
Patients with thymoma who have undergone surgery within the past 6 months.
Patients with malignancies other than thymoma.
First Affiliated Hospital of Wenzhou Medical University
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator