Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT07231523
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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;
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.
Time frame: From baseline to 2 weeks postoperatively
The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.
Time frame: From baseline to 2 weeks postoperatively
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
The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.
Time frame: From baseline to 1 day preoperatively
The change in the QMG score from baseline to 1 day preoperatively
Time frame: From baseline to 1 week postoperatively
The change in the QMG score from baseline to 1 week postoperatively
Time frame: From baseline to 1 month postoperatively
The change in the QMG score from baseline to 1 month postoperatively
Time frame: From baseline to 2 months postoperatively
The change in the QMG score from baseline to 2 months postoperatively
Time frame: From baseline to 1 day preoperatively
The change in the MG-ADL score from baseline to 1 day preoperatively
Time frame: From baseline to 1 week postoperatively
The change in the MG-ADL score from baseline to 1 week postoperatively
Time frame: From baseline to 1 month postoperatively
The change in the MG-ADL score from baseline to 1 month postoperatively
Time frame: From baseline to 2 months postoperatively
The change in the MG-ADL score from baseline to 2 months postoperatively
Time frame: From baseline to 1 day preoperatively
The change in the MGC score from baseline to 1 day preoperatively
Time frame: From baseline to 1 week postoperatively
The change in the MGC score from baseline to 1 week postoperatively
Time frame: From baseline to 1 month postoperatively
The change in the MGC score from baseline to 1 month postoperatively
Time frame: From baseline to 2 months postoperatively
The change in the MGC score from baseline to 2 months postoperatively
Time frame: From baseline to 1 day preoperatively
The reduction in the IgG level from baseline to 1 day preoperatively
Time frame: From baseline to 1 week postoperatively
The reduction in the IgG level from baseline to 1 week postoperatively
Time frame: From baseline to 2 weeks postoperatively
The reduction in the IgG level from baseline to 2 weeks postoperatively
Time frame: From baseline to 1 month postoperatively
The reduction in the IgG level from baseline to 1 month postoperatively
Time frame: From baseline to 2 months postoperatively
The reduction in the IgG level from baseline to 2 months postoperatively
Time frame: From baseline to 1 day preoperatively
The reduction in the AChR-Ab level from baseline to 1 day preoperatively
Time frame: From baseline to 2 weeks postoperatively
The reduction in the AChR-Ab level from baseline to 2 weeks postoperatively
Time frame: From baseline to 1 month postoperatively
The reduction in the AChR-Ab level from baseline to 1 month postoperatively
Time frame: From baseline to 2 months postoperatively
The rate of reduction in steroid dose from baseline to 2 months postoperatively
Time frame: Perioperative period
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
The incidence of total perioperative complications assessed by Clavien-Dindo classification
Time frame: Perioperative period
The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification.
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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