A Study in Patients With Myasthenia Gravis in China

Recruiting

• Conditions: Myasthenia Gravis

• Registration Number: NCT06700616
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-26
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome	Every 6 months up to 3 years	Death
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	EuroQol-5D (separate value for five dimensions in a scale for quality of life)
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 Outcome Measures

Name	Time	Method
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)
Vital sign - blood pressure	Every 6 months up to 3 years	Blood pressure (mmHg)
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 healthcare costs
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Wuhan, China