A Study in Patients With Myasthenia Gravis in China
MG Cohort
A Multicenter, Prospective Cohort Study in Patients With Myasthenia Gravis in China
1 other identifier
observational
1,199
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2024
CompletedFirst Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
March 16, 2026
March 1, 2026
3.3 years
September 30, 2024
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Clinical outcome
MGFA classification (e.g I, II, III, IV, V)
Every 6 months up to 3 years
Treatment method
Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
Every 6 months up to 3 years
Patient-reported outcome
MG-Activities of Daily Living (MG-ADL, aggregated value in a scale, ranged 0- best to 24- worst)
Every 6 months up to 3 years
Clinical outcome
MGFA Post-intervention Status (e.g. CSR, PR, MM)
Every 6 months up to 3 years
Clinical outcome
Quantitative MG score (QMG, aggregated value in a scale, ranged 0- best to 39-worst)
Every 6 months up to 3 years
Clinical outcome
Physician-reported MG crisis
Every 6 months up to 3 years
Clinical outcome
Death
Every 6 months up to 3 years
Patient-reported outcome
MG-Quality of Life 15-Revised (MG-QoL15-r, aggregated value in a scale for quality of life, ranged 0- best to 60- worst)
Every 6 months up to 3 years
Patient-reported outcome
EuroQol-5D (separate value for five dimensions in a scale for quality of life)
Every 6 months up to 3 years
Treatment duration
Therapies start and end date
Every 6 months up to 3 years
Treatment dose
Dose (e.g. mg)
Every 6 months up to 3 years
Treatment frequency
Frequency (e.g. times/day)
Every 6 months up to 3 years
Secondary Outcomes (9)
Demographic factors
Baseline
Healthcare resource utilization
Every 6 months up to 3 years
Cormobidity
Every 6 months up to 3 years
Healthcare resource utilization
Every 6 months up to 3 years
MG diagnosis history
Every 6 months up to 3 years
- +4 more secondary outcomes
Eligibility Criteria
This study will recruit patients diagnosed with MG by a physician. The diagnosis of MG patients newly diagnosed prior to enrollment should be based on the clinical characteristics of MG and at least one of the following criteria: (a) Positive serology tests for acetylcholine receptor antibody (AChR Ab), muscle-specific kinase antibody (MuSK Ab), or lipoprotein-related protein 4 (LRP4 Ab); (b) Results of electrophysiological studies (repetitive stimulation, single-fiber electromyography, or both) related to synaptic transmission disorder at the neuromuscular junction; (c) Positive pharmacological test results (such as neostigmine methylsulfate test). Previously diagnosed patients must have a documented MG diagnosis accepted by clinical physician.
You may qualify if:
- This study will enroll patients of all ages who are diagnosed with MG of all MGFA classifications by physicians.
- Patients must have the following data to be enrolled in this study:
- MGFA classification
- MG-ADL score
- MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).
You may not qualify if:
- Patients aged ≥18 years with ocular myasthenia gravis (MGFA class I) lasting for more than 2 years;
- Patients who are currently participating in an interventional clinical trial cannot be enrolled in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guiyang, China
Research Site
Harbin, China
Research Site
Hebei, China
Research Site
Henan, China
Research Site
Inner Mongolia, China
Research Site
Jiangsu, China
Research Site
Lanzhou, China
Research Site
Nanning, China
Research Site
Qingdao, China
Research Site
Taiyuan, China
Research Site
Tianjin, China
Research Site
Ürümqi, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Research Site
Yinchuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fudong Shi, MD, PhD
Beijing Tiantan Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
November 22, 2024
Study Start
September 26, 2024
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.