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NCT06241521Recruiting

Myasthenia Gravis Registry in China

Source: ClinicalTrials.gov · Last updated 5 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Myasthenia gravis (MG) is an autoimmune disease caused by dysfunction at the neuromuscular junction, characterized by partial or generalized skeletal muscle weakness and fatigability. The estimated annual incidence rate of MG in China is 0.68/100,000, with a high rate of relapse and poor treatment compliance. This study is a prospective, observational, multi-center patient registry across China. To support standardized management and follow-up of MG patients in China, a Cloud-based MG Patient Management Platform (CN MG Base) was established in September 2023 with the support of the Chinese Rare Diseases Alliance. The platform aims to collect longitudinal clinical data including demographic information, age of onset, medical history, comorbidities, medication usage, treatment responses, and others. It is intended to collect newly registered MG cases each year and follow up with these patients at one-year intervals for ten years

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
27 Jan 2024
Start date
1 Feb 2024
Primary completion date
1 Feb 2034
Lead sponsor
Huashan Hospital
NCT number
NCT06241521

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 1 Feb 2024 to the primary completion date, 1 Feb 2034
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with mental illness who cannot cooperate.
  • Patients with multiple organ dysfunction or in extremely critical condition, unable to complete relevant medical history collection or evaluation.

Who the study is looking for

  • Fluctuating weakness in skeletal muscles, such as extraocular, bulbar, limb muscles, etc.. Demonstrating fluctuation and fatigability: Weakness is usually worse in the morning and improves with rest; worsens with sustained activity.
  • Patients themselves or their guardians can understand and sign the informed consent form.
    • To meet the eligibility criteria, at least one of the following additional criteria must be met:
  • a. Positive Tensilon test;
  • b. Decrease in compound muscle action potential by more than 10% with low-frequency repetitive nerve stimulation or widening of the "jitter" (the variability in time of the second action potential relative to the first) on single-fiber electromyography, with or without blocking;
  • c. Positive antibodies: Serum testing positive for AChR antibodies, MuSK antibodies, or LRP4 antibodies.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Beijing Hospital
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BeijingChinaRecruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaRecruiting
The First Hospital, Jilin University
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ChangchunChinaRecruiting
Xiangya Hospital Central South University
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ChangshaChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The Third Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
The First Hospital, Soochow University
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SuzhouChinaRecruiting
Tianjin Medical University General Hospital
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TianjinChinaRecruiting
Tangdu Hospital, The Air Force Medical University
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Xi’anChinaRecruiting
Affiliated Hospital of Xuzhou Medical University
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XuzhouChinaRecruiting
First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.