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It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod Alfa | Drug | Efgartigimod will be administered intravenously on Day (D)1, D8, D15, and D22 at a dose of 10 mg/kg according to the patient's weight (maximum infusion dose of 1200 mg) over approximately 1 hour for a total of 4 doses. Thymectomy will be performed on Day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the activity of daily living (ADL) score at the fourth visit from the baseline visit (first visit) | The value was calculated by the ADL score at the fourth visit minus the ADL score at the first visit (baseline). | Baseline and 3 weeks after the first visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the ADL score at the second visit from the baseline visit (first visit) | The value was calculated by the ADL score at the second visit minus the ADL score at the first visit (baseline). | Baseline and 1 day before surgery (always at the 1 week after the first visit). |
| Change of quantitative myasthenia gravis (QMG) score at the second visit from the baseline visit (first visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40320172 | Derived | Wang S, Zhu M, Dong J, Zhang Y, Luo S, Jiang J, Cheng Z, Li Z, Yang W, Yu Y, Liu Z, Fan J, Xu X, Liu P, Zhang Z, Can F, Liang F, Jiang X, Tan L, Ding J. Perioperative Safety and Efficacy of Efgartigimod for Thymoma-Associated Myasthenia Gravis: A Prospective, Multicenter, Phase II Clinical Trial. J Thorac Oncol. 2025 Aug;20(8):1120-1130. doi: 10.1016/j.jtho.2025.04.014. Epub 2025 May 2. |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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The value was calculated by the QMG score at the second visit minus the QMG score at the first visit (baseline). |
| Baseline and 1 day before surgery (always at the 1 week after the first visit). |
| Change of myasthenia gravis composite (MGC) score at the second visit from the baseline visit (first visit) | The value was calculated by the MGC score at the second visit minus the MGC score at the first visit (baseline). | Baseline and 1 day before surgery (always at the 1 week after the first visit). |
| Change of QMG score at the fourth visit from the baseline visit (first visit) | The value was calculated by the QMG score at the fourth visit minus the QMG score at the first visit (baseline). | Baseline and 3 weeks after the first visit. |
| Change of MGC score at the fourth visit from the baseline visit (first visit) | The value was calculated by the MGC score at the fourth visit minus the MGC score at the first visit (baseline). | Baseline and 3 weeks after the first visit. |
| Change of lgG-AChR level at the fourth visit from the baseline visit (first visit) | The value (percent) was calculated by the lgG-AChR level at the fourth visit minus the lgG-AChR level score at the first visit (baseline). | Baseline and 3 weeks after the first visit. |
| The rate of postoperative myasthenia crisis | From the day when trial begin to the day when the follow-up is ended. Up to 48 weeks. |
| Postoperative hospital stay | From the day when trial begin to the day when the follow-up is ended. Up to 48 weeks. |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |