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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
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.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Quantitative Myasthenia Gravis (QMG) reduction
The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.
Time frame: From baseline to 2 weeks postoperatively
Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction
The total MG-ADL score ranges from 0 to 24, with higher scores indicating more severe condition
Time frame: From baseline to 2 weeks postoperatively
Myasthenia Gravis Composite (MGC) reduction
The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.
Time frame: From baseline to 2 weeks postoperatively
QMG change (1 day preoperatively)
The change in the QMG score from baseline to 1 day preoperatively
Time frame: From baseline to 1 day preoperatively
QMG change (1 week postoperatively)
The change in the QMG score from baseline to 1 week postoperatively
Time frame: From baseline to 1 week postoperatively
QMG change (1 month postoperatively)
The change in the QMG score from baseline to 1 month postoperatively
Time frame: From baseline to 1 month postoperatively
QMG change (2 months postoperatively)
The change in the QMG score from baseline to 2 months postoperatively
Time frame: From baseline to 2 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MG-ADL change (1 day preoperatively)
The change in the MG-ADL score from baseline to 1 day preoperatively
Time frame: From baseline to 1 day preoperatively
MG-ADL change (1 week postoperatively)
The change in the MG-ADL score from baseline to 1 week postoperatively
Time frame: From baseline to 1 week postoperatively
MG-ADL change (1 month postoperatively)
The change in the MG-ADL score from baseline to 1 month postoperatively
Time frame: From baseline to 1 month postoperatively
MG-ADL change (2 months postoperatively)
The change in the MG-ADL score from baseline to 2 months postoperatively
Time frame: From baseline to 2 months postoperatively
MGC change (1 day preoperatively)
The change in the MGC score from baseline to 1 day preoperatively
Time frame: From baseline to 1 day preoperatively
MGC change (1 week postoperatively)
The change in the MGC score from baseline to 1 week postoperatively
Time frame: From baseline to 1 week postoperatively
MGC change (1 month postoperatively)
The change in the MGC score from baseline to 1 month postoperatively
Time frame: From baseline to 1 month postoperatively
MGC change (2 months postoperatively)
The change in the MGC score from baseline to 2 months postoperatively
Time frame: From baseline to 2 months postoperatively
IgG reduction (1 day preoperatively)
The reduction in the IgG level from baseline to 1 day preoperatively
Time frame: From baseline to 1 day preoperatively
IgG reduction (1 week postoperatively)
The reduction in the IgG level from baseline to 1 week postoperatively
Time frame: From baseline to 1 week postoperatively
IgG reduction (2 weeks postoperatively)
The reduction in the IgG level from baseline to 2 weeks postoperatively
Time frame: From baseline to 2 weeks postoperatively
IgG reduction (1 month postoperatively)
The reduction in the IgG level from baseline to 1 month postoperatively
Time frame: From baseline to 1 month postoperatively
IgG reduction (2 months postoperatively)
The reduction in the IgG level from baseline to 2 months postoperatively
Time frame: From baseline to 2 months postoperatively
AChR-Ab reduction (1 day preoperatively)
The reduction in the AChR-Ab level from baseline to 1 day preoperatively
Time frame: From baseline to 1 day preoperatively
AChR-Ab reduction (2 weeks postoperatively)
The reduction in the AChR-Ab level from baseline to 2 weeks postoperatively
Time frame: From baseline to 2 weeks postoperatively
AChR-Ab reduction (1 month postoperatively)
The reduction in the AChR-Ab level from baseline to 1 month postoperatively
Time frame: From baseline to 1 month postoperatively
Proportion of steroid dose reduction
The rate of reduction in steroid dose from baseline to 2 months postoperatively
Time frame: From baseline to 2 months postoperatively
Incidence of myasthenic crisis
The incidence of postoperative myasthenia gravis crisis, from the start of the trial to the end of the follow-up period
Time frame: Perioperative period
Incidence of total perioperative complications (≥3)
The incidence of total perioperative complications assessed by Clavien-Dindo classification
Time frame: Perioperative period
Incidence of perioperative infection-related complications
The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification.
Time frame: Perioperative period