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NCT04674605 Clinical Trial

A Prospective Cohort Study Of Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:
A Prospective Cohort Study Of Myasthenia Gravis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04674605
Other study ID # 2020-382
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2020
Est. completion date October 30, 2022

Study information
Verified date December 2020
Source First Affiliated Hospital of Chongqing Medical University
Contact Fei Xiao, MD
Phone 86 23 89012009
Email feixiao81@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed. This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 30, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 80 Years
Eligibility Inclusion Criteria: - Meeting the diagnosis of myasthenia gravis Exclusion Criteria: - Malignant tumor or other serious chronic disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• biomarkers
biomarkers

Locations
Country Name City State
China The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China The First Affiliated Hospital of Chongqing Medical University Chongqing YuZhong District

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Myasthenia gravis foundation of America post intervention status Complete Stable Remission (CSR) Pharmacologic Remission (PR) Minimal Manifestations (MM) Change in Status: Improved (I) Unchanged (U) Worse (W) Exacerbation (E) Died of MG (D of MG) 3 years
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