A Study in Patients With Myasthenia Gravis in China

NCT ID: NCT06700616

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-26

Study Completion Date

2027-12-30

Brief Summary

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This study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (PROs), disease prognosis, treatment patterns and healthcare resource utilization for Chinese patients with myasthenia gravis (MG). This study will enroll patients with MG as diagnosed by physician. Approximately 1,200 MG patients are intended to be recruited from approximately 40 sites across majority of regions in China. The clinical and PROs included MGFA class, MGFA PIS, MG-ADL (Activities of Daily Living), QMG (Quantitative MG score), MG QOL-15R, EQ-5D etc. All MG patients enrolled will be followed up every 6 months until end of 2027.

Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

This study will enroll patients of all ages who are diagnosed with MG of all MGFA classifications by physicians.

1. Patients must have the following data to be enrolled in this study:

* MGFA classification
* MG-ADL score
2. MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).

Exclusion Criteria

1. Patients aged ≥18 years with ocular myasthenia gravis (MGFA class I) lasting for more than 2 years;
2. Patients who are currently participating in an interventional clinical trial cannot be enrolled in this study.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fudong Shi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Research Site

Beijing, , China

Site Status

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Chengdu, , China

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Fuzhou, , China

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Guangzhou, , China

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Guiyang, , China

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Harbin, , China

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Hebei, , China

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Henan, , China

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Inner Mongolia, , China

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Jiangsu, , China

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Lanzhou, , China

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Nanning, , China

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Qingdao, , China

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Taiyuan, , China

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Tianjin, , China

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Ürümqi, , China

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Wenzhou, , China

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Wuhan, , China

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Xi'an, , China

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Yinchuan, , China

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Countries

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China

Other Identifiers

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D9030R00001

Identifier Type: -

Identifier Source: org_study_id

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