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| Name | Class |
|---|---|
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod + Thymectomy | Experimental |
| |
| Intravenous immunglobulin + Thymectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod + Thymectomy | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Myasthenia Gravis (QMG) reduction | The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition. | From baseline to 2 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to 2 weeks postoperatively |
| Myasthenia Gravis Composite (MGC) reduction |
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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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianyong Ding | Contact | +86 18616881268 | ding.jianyong@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D013934 | Thymectomy |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Tang-Du Hospital | OTHER |
| West China Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Huashan Hospital | OTHER |
| The Affiliated Brain Hospital of Nanjing Medical University | OTHER_GOV |
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Wuhan TongJi Hospital | OTHER |
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| Intravenous immunglobulin + Thymectomy | Combination Product | 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. |
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The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.
| From baseline to 2 weeks postoperatively |
| QMG change (1 day preoperatively) | The change in the QMG score from baseline to 1 day preoperatively | From baseline to 1 day preoperatively |
| QMG change (1 week postoperatively) | The change in the QMG score from baseline to 1 week postoperatively | From baseline to 1 week postoperatively |
| QMG change (1 month postoperatively) | The change in the QMG score from baseline to 1 month postoperatively | From baseline to 1 month postoperatively |
| QMG change (2 months postoperatively) | The change in the QMG score from baseline to 2 months postoperatively | From baseline to 2 months postoperatively |
| MG-ADL change (1 day preoperatively) | The change in the MG-ADL score from baseline to 1 day preoperatively | 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 | 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 | 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 | From baseline to 2 months postoperatively |
| MGC change (1 day preoperatively) | The change in the MGC score from baseline to 1 day preoperatively | From baseline to 1 day preoperatively |
| MGC change (1 week postoperatively) | The change in the MGC score from baseline to 1 week postoperatively | From baseline to 1 week postoperatively |
| MGC change (1 month postoperatively) | The change in the MGC score from baseline to 1 month postoperatively | From baseline to 1 month postoperatively |
| MGC change (2 months postoperatively) | The change in the MGC score from baseline to 2 months postoperatively | From baseline to 2 months postoperatively |
| IgG reduction (1 day preoperatively) | The reduction in the IgG level from baseline to 1 day preoperatively | From baseline to 1 day preoperatively |
| IgG reduction (1 week postoperatively) | The reduction in the IgG level from baseline to 1 week postoperatively | From baseline to 1 week postoperatively |
| IgG reduction (2 weeks postoperatively) | The reduction in the IgG level from baseline to 2 weeks postoperatively | From baseline to 2 weeks postoperatively |
| IgG reduction (1 month postoperatively) | The reduction in the IgG level from baseline to 1 month postoperatively | From baseline to 1 month postoperatively |
| IgG reduction (2 months postoperatively) | The reduction in the IgG level from baseline to 2 months postoperatively | 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 | 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 | 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 | From baseline to 1 month postoperatively |
| Proportion of steroid dose reduction | The rate of reduction in steroid dose from baseline to 2 months postoperatively | 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 | Perioperative period |
| Incidence of total perioperative complications (≥3) | The incidence of total perioperative complications assessed by Clavien-Dindo classification | Perioperative period |
| Incidence of perioperative infection-related complications | The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification. | Perioperative period |