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.
Study Type
OBSERVATIONAL
Enrollment
1,199
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
...and 10 more locations
Clinical outcome
MGFA classification (e.g I, II, III, IV, V)
Time frame: Every 6 months up to 3 years
Treatment method
Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
Time frame: 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)
Time frame: Every 6 months up to 3 years
Clinical outcome
MGFA Post-intervention Status (e.g. CSR, PR, MM)
Time frame: Every 6 months up to 3 years
Clinical outcome
Quantitative MG score (QMG, aggregated value in a scale, ranged 0- best to 39-worst)
Time frame: Every 6 months up to 3 years
Clinical outcome
Physician-reported MG crisis
Time frame: Every 6 months up to 3 years
Clinical outcome
Death
Time frame: 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)
Time frame: Every 6 months up to 3 years
Patient-reported outcome
EuroQol-5D (separate value for five dimensions in a scale for quality of life)
Time frame: Every 6 months up to 3 years
Treatment duration
Therapies start and end date
Time frame: Every 6 months up to 3 years
Treatment dose
Dose (e.g. mg)
Time frame: Every 6 months up to 3 years
Treatment frequency
Frequency (e.g. times/day)
Time frame: Every 6 months up to 3 years
Demographic factors
1. Age (years) 2. Gender (male, female) 3. Residence place (rural, urban) 4. Education 5. Household income
Time frame: Baseline
Healthcare resource utilization
MG-related hospitalization (days)
Time frame: Every 6 months up to 3 years
Cormobidity
Comorbidities (list of related diseases, e.g. autoimmune diseases, cardiovascular disease, hypertension, diabetes etc.)
Time frame: Every 6 months up to 3 years
Healthcare resource utilization
MG-related healthcare costs
Time frame: Every 6 months up to 3 years
MG diagnosis history
MG first time diagnosis date
Time frame: Every 6 months up to 3 years
Vital sign - blood pressure
Blood pressure (mmHg)
Time frame: Every 6 months up to 3 years
Laboratory test - blood cell test
Blood cell counts by cell type tests (e.g. counts/L)
Time frame: Every 6 months up to 3 years
Laboratory tests etc.) - MG-related antibodies
MG-related antibodies including AChR, MuSK, LRP4 etc. (positive or negative).
Time frame: Every 6 months up to 3 years
Vital sign - pulse
Pulse (count/minute)
Time frame: Every 6 months up to 3 years
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