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The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC18 160mg | Experimental | Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times. |
|
| RC18 240 mg | Experimental | Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC18 160mg | Biological | subcutaneous injection |
| |
| RC18 240 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline | QMG score=Quantitative Myasthenia Gravis Score | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The average variation of clinical absolute score for myasthenia gravis of the twelfth and twenty-fourth weeks compared to Clinical absolute score for myasthenia gravis of baseline | It is best that the assessors in each center are fixed during the study. | week 12,24 |
| The average variation of QMG score of the twelfth week compared to the OMG scores of baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xianhao Xu, M.D. | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | China | |||
| The First Affiliated Hospital of USTC;Anhui Provincial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38726639 | Result | Yin J, Zhao M, Xu X, Zhang M, Xu Z, Li Z, Qin X, Li Z, Zhao C, Zhou H, Ma Y, Cao W, Wang G, Lin Y, Zhang J, Zhang X, Cai H, Qian W, Wang Y, Zhang X, Liu G, Wang J, Qiu W, Min L, Li J, Deng H, Chu L, Zhang Y, Fang J. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024 Aug;31(8):e16322. doi: 10.1111/ene.16322. Epub 2024 May 10. |
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| Biological |
subcutaneous injection |
|
QMG score=Quantitative Myasthenia Gravis Score |
| week 12 |
| Hefei |
| Anhui |
| China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | China |
| Nanyang First People's Hospital | Nanyang | Henan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| The First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Liaoning | China |
| The Second Affiliated Hospital of Air Force Medical University | Xi'an | Shaanxi | China |
| West China Hospital, Sichuan University | Xi'an | Shaanxi | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| West China School of Medicine;West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China |
| Beijing Hospital | Beijing | China |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | China |
| The Second Hospital & Clinical medical school ; Lanzhou University | Lanzhou | China |
| Huashan Hospital, Fudan University | Shanghai | China |
| ID | Term |
|---|---|
| C035529 | RC-18 |
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