Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

Myasthenia Gravis Clinical Trial

Official title:

Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535843
• Other study ID #: 2020-999
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: January 2024
• Source: Huashan Hospital
• Contact: Chongbo Zhao, MD
• Phone: 86-021-52889999
• Email: zhao_chongbo[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 90 Years

Eligibility

Inclusion Criteria:

• fluctuating muscle weakness and fatigability, along with one of the below:
• more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
• anti-AChR or MuSK antibody positivity;
• positive to the neostigmine test;
• understanding and assigning the informed consent form, and having a good compliance with the follow up.

Exclusion Criteria:

• excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
• participating other clinical trials;
• poor compliance to the follow up.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Device:
• pheripheral biomarkers
Detect the pheripheral biomarkers,including lymphocytes and cytokines, in this prospective MG cohort.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Huashan Hospital	Shanghai
China	Obsterics and Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myasthenia gravis foundation of America post intervention status	Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up. According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record).	3 years
Secondary	Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up	A quantitative MG scoring system (QMG Score) is essential in the objective evaluation of therapy for MG.This scoring system is based on quantitative testing of sentinel muscle groups. Total QMG score range from 0 (extreme disease severity) to 39 (none), higher score indicated less disease severity.	Baseline, 1 year, 2 year, and 3 year
Secondary	Change From Baseline in Manual Muscle Testing (MMT) Scores at the follow up	The MMT score is the sum of strength or function values assigned by the examining physician to 30 muscle groups usually affected by MG. Total MMT score range from 0 (none) to 124 (extreme muscle weakness), higher score indicated more disease severity.	Baseline, 1 year, 2 year, and 3 year
Secondary	Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up	The MG-QOL15 is helpful in informing the clinician about the patient's perception of the extent of and dissatisfaction with MG-related dysfunction. Total MG-QOL15 score range from 0 (none) to 60 (extreme disease severity), higher score indicated more disease severity.	Baseline, 1 year, 2 year, and 3 year