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NCT Number: NCT06700616

A Study in Patients With Myasthenia Gravis in China

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Clinical outcome

    Time frame: Every 6 months up to 3 years

    MGFA classification (e.g I, II, III, IV, V)

  2. Treatment method

    Time frame: Every 6 months up to 3 years

    Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )

  3. Patient-reported outcome

    Time frame: 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)

  4. Clinical outcome

    Time frame: Every 6 months up to 3 years

    MGFA Post-intervention Status (e.g. CSR, PR, MM)

  5. Clinical outcome

    Time frame: Every 6 months up to 3 years

    Quantitative MG score (QMG, aggregated value in a scale, ranged 0- best to 39-worst)

  6. Clinical outcome

    Time frame: Every 6 months up to 3 years

    Physician-reported MG crisis

  7. Clinical outcome

    Time frame: Every 6 months up to 3 years

    Death

  8. Patient-reported outcome

    Time frame: Every 6 months up to 3 years

    MG-Quality of Life 15-Revised (MG-QoL15-r, aggregated value in a scale for quality of life, ranged 0- best to 60- worst)

  9. Patient-reported outcome

    Time frame: Every 6 months up to 3 years

    EuroQol-5D (separate value for five dimensions in a scale for quality of life)

  10. Treatment duration

    Time frame: Every 6 months up to 3 years

    Therapies start and end date

  11. Treatment dose

    Time frame: Every 6 months up to 3 years

    Dose (e.g. mg)

  12. Treatment frequency

    Time frame: Every 6 months up to 3 years

    Frequency (e.g. times/day)

Secondary outcomes

  1. Demographic factors

    Time frame: Baseline

    • Age (years)
    • Gender (male, female)
    • Residence place (rural, urban)
    • Education
    • Household income

  2. Healthcare resource utilization

    Time frame: Every 6 months up to 3 years

    MG-related hospitalization (days)

  3. Cormobidity

    Time frame: Every 6 months up to 3 years

    Comorbidities (list of related diseases, e.g. autoimmune diseases, cardiovascular disease, hypertension, diabetes etc.)

  4. Healthcare resource utilization

    Time frame: Every 6 months up to 3 years

    MG-related healthcare costs

  5. MG diagnosis history

    Time frame: Every 6 months up to 3 years

    MG first time diagnosis date

  6. Vital sign - blood pressure

    Time frame: Every 6 months up to 3 years

    Blood pressure (mmHg)

  7. Laboratory test - blood cell test

    Time frame: Every 6 months up to 3 years

    Blood cell counts by cell type tests (e.g. counts/L)

  8. Laboratory tests etc.) - MG-related antibodies

    Time frame: Every 6 months up to 3 years

    MG-related antibodies including AChR, MuSK, LRP4 etc. (positive or negative).

  9. Vital sign - pulse

    Time frame: Every 6 months up to 3 years

    Pulse (count/minute)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: MG Cohort

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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