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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Myasthenia Gravis Crisis

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