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NCT Number: NCT04535843

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

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

0 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • poor compliance to the follow up.

Treatment and study plan

Biomarkers and omics data

Other

To detect disease-related biomarkers and omics data, in this prospective MG cohort.

Primary outcomes

  1. Myasthenia gravis foundation of America post intervention status

    Time frame: 3 years

    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).

Secondary outcomes

  1. Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up

    Time frame: Baseline, 1 year, 2 year, and 3 year

    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.

  2. Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up

    Time frame: Baseline, 1 year, 2 year, and 3 year

    The MG-ADL scale assesses the impact of MG on patients' daily functions. Physicians use this tool to score a patient's MG symptoms based on the patient's recall of symptoms during the prior week. A person's score can range from zero (normal) to 24 (most severe).

  3. Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up

    Time frame: Baseline, 1 year, 2 year, and 3 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chongbo Zhao, MD

CONTACT

[email protected]

86-021-52889999

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2020
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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