A Study in Patients With Myasthenia Gravis in China

A Multicenter, Prospective Cohort Study in Patients With Myasthenia Gravis in China

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06700616

Acronym

MG Cohort

Enrollment

1199

Registered

2024-11-22

Start date

2024-09-26

Completion date

2027-12-30

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis, Generalized Myasthenia Gravis, Refractory Myasthenia Gravis, Prospective Study, Observational Study, Cohort Study, Patient Registry, Chinese

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical outcome	Every 6 months up to 3 years	MGFA classification (e.g I, II, III, IV, V)
Treatment method	Every 6 months up to 3 years	Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
Patient-reported outcome	Every 6 months up to 3 years	MG-Activities of Daily Living (MG-ADL, aggregated value in a scale, ranged 0- best to 24- worst)
Treatment duration	Every 6 months up to 3 years	Therapies start and end date
Treatment dose	Every 6 months up to 3 years	Dose (e.g. mg)
Treatment frequency	Every 6 months up to 3 years	Frequency (e.g. times/day)

Secondary

Measure	Time frame	Description
Demographic factors	Baseline	1. Age (years) 2. Gender (male, female) 3. Residence place (rural, urban) 4. Education 5. Household income
Healthcare resource utilization	Every 6 months up to 3 years	MG-related hospitalization (days)
Cormobidity	Every 6 months up to 3 years	Comorbidities (list of related diseases, e.g. autoimmune diseases, cardiovascular disease, hypertension, diabetes etc.)
MG diagnosis history	Every 6 months up to 3 years	MG first time diagnosis date
Vital sign - blood pressure	Every 6 months up to 3 years	Blood pressure (mmHg)
Laboratory test - blood cell test	Every 6 months up to 3 years	Blood cell counts by cell type tests (e.g. counts/L)
Laboratory tests etc.) - MG-related antibodies	Every 6 months up to 3 years	MG-related antibodies including AChR, MuSK, LRP4 etc. (positive or negative).
Vital sign - pulse	Every 6 months up to 3 years	Pulse (count/minute)

Countries

China

Contacts

PRINCIPAL_INVESTIGATORFudong Shi, MD, PhD

Beijing Tiantan Hospital

Outcome results