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Active, not recruitingNCT06700616MG CohortUpdated Sep 18, 2026

A Study in Patients With Myasthenia Gravis in China

An observational study in Myasthenia Gravis, sponsored by AstraZeneca. Active, not recruiting at 20 sites in China. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,199
Ages
0 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myasthenia Gravis

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Keywords

  • Myasthenia Gravis
  • Generalized Myasthenia Gravis
  • Refractory Myasthenia Gravis
  • Prospective Study
  • Observational Study
  • Cohort Study
  • Patient Registry
  • Chinese
03

In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's enrollment of 1,199 is above the median of 140 across 104 observational studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,199 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical outcome

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

    Time frame: Every 6 months up to 3 years

  2. Treatment method

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

    Time frame: Every 6 months up to 3 years

  3. 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

  4. Clinical outcome

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

    Time frame: Every 6 months up to 3 years

  5. 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

  6. Clinical outcome

    Physician-reported MG crisis

    Time frame: Every 6 months up to 3 years

  7. Clinical outcome

    Death

    Time frame: Every 6 months up to 3 years

  8. 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

  9. 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

  10. Treatment duration

    Therapies start and end date

    Time frame: Every 6 months up to 3 years

  11. Treatment dose

    Dose (e.g. mg)

    Time frame: Every 6 months up to 3 years

  12. Treatment frequency

    Frequency (e.g. times/day)

    Time frame: Every 6 months up to 3 years

Secondary outcomes

  1. Demographic factors

    1. Age (years) 2. Gender (male, female) 3. Residence place (rural, urban) 4. Education 5. Household income

    Time frame: Baseline

  2. Healthcare resource utilization

    MG-related hospitalization (days)

    Time frame: Every 6 months up to 3 years

  3. Cormobidity

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

    Time frame: Every 6 months up to 3 years

  4. Healthcare resource utilization

    MG-related healthcare costs

    Time frame: Every 6 months up to 3 years

  5. MG diagnosis history

    MG first time diagnosis date

    Time frame: Every 6 months up to 3 years

  6. Vital sign - blood pressure

    Blood pressure (mmHg)

    Time frame: Every 6 months up to 3 years

  7. 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

  8. 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

  9. Vital sign - pulse

    Pulse (count/minute)

    Time frame: Every 6 months up to 3 years

07

Study locations

20 sites
  • 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
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06700616
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Nov 22, 2024
Start date
Sep 26, 2024
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Fudong Shi, MD, PhD
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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