Myasthenia GravisMG CohortNCT06700616
A Study in Patients With Myasthenia Gravis in China
An observational study of Myasthenia Gravis, run by AstraZeneca at 20 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 1,199 participants
- Where
- 20 sitesChina
- Study dates
- 26 Sep 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Research Site
Beijing
Research Site
Chengdu
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Guiyang
Research Site
Harbin
Research Site
Hebei
Research Site
Henan
Research Site
Inner Mongolia
Research Site
Jiangsu
Research Site
Lanzhou
Research Site
Nanning
Research Site
Qingdao
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Ürümqi
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Xi'an
Research Site
Yinchuan
About this study
Official title: A Multicenter, Prospective Cohort 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.
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Generalized Myasthenia Gravis, Refractory Myasthenia Gravis, Prospective Study, Observational Study, Cohort Study, Patient Registry, Chinese
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
MGFA classification (e.g I, II, III, IV, V)
Measured: Every 6 months up to 3 years
Treatment method
Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
Measured: 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)
Measured: Every 6 months up to 3 years
Clinical outcome
MGFA Post-intervention Status (e.g. CSR, PR, MM)
Measured: Every 6 months up to 3 years
Clinical outcome
Quantitative MG score (QMG, aggregated value in a scale, ranged 0- best to 39-worst)
Measured: Every 6 months up to 3 years
Clinical outcome
Physician-reported MG crisis
Measured: Every 6 months up to 3 years
Clinical outcome
Death
Measured: 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)
Measured: Every 6 months up to 3 years
Patient-reported outcome
EuroQol-5D (separate value for five dimensions in a scale for quality of life)
Measured: Every 6 months up to 3 years
Treatment duration
Therapies start and end date
Measured: Every 6 months up to 3 years
Treatment dose
Dose (e.g. mg)
Measured: Every 6 months up to 3 years
Treatment frequency
Frequency (e.g. times/day)
Measured: Every 6 months up to 3 years
Secondary outcomes (9)
Demographic factors
- Age (years)
- Gender (male, female)
- Residence place (rural, urban)
- Education
- Household income
Measured: Baseline
Healthcare resource utilization
MG-related hospitalization (days)
Measured: Every 6 months up to 3 years
Cormobidity
Comorbidities (list of related diseases, e.g. autoimmune diseases, cardiovascular disease, hypertension, diabetes etc.)
Measured: Every 6 months up to 3 years
Healthcare resource utilization
MG-related healthcare costs
Measured: Every 6 months up to 3 years
MG diagnosis history
MG first time diagnosis date
Measured: Every 6 months up to 3 years
Vital sign - blood pressure
Blood pressure (mmHg)
Measured: Every 6 months up to 3 years
Laboratory test - blood cell test
Blood cell counts by cell type tests (e.g. counts/L)
Measured: Every 6 months up to 3 years
Laboratory tests etc.) - MG-related antibodies
MG-related antibodies including AChR, MuSK, LRP4 etc. (positive or negative).
Measured: Every 6 months up to 3 years
Vital sign - pulse
Pulse (count/minute)
Measured: Every 6 months up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start26 Sep 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fudong Shi, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700616
- Sponsor's protocol ID
- D9030R00001
- Acronym
- MG Cohort
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study in Patients With Myasthenia Gravis in China
- ClinicalTrials.gov ID
- NCT06700616
- Acronym / sponsor ID
- MG Cohort / D9030R00001
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Generalized Myasthenia Gravis, Refractory Myasthenia Gravis, Prospective Study, Observational Study, Cohort Study, Patient Registry, Chinese
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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:
- MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome
Time frame: Every 6 months up to 3 years
MGFA classification (e.g I, II, III, IV, V)
Treatment method
Time frame: Every 6 months up to 3 years
Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. )
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)
Clinical outcome
Time frame: Every 6 months up to 3 years
MGFA Post-intervention Status (e.g. CSR, PR, MM)
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)
Clinical outcome
Time frame: Every 6 months up to 3 years
Physician-reported MG crisis
Clinical outcome
Time frame: Every 6 months up to 3 years
Death
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)
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)
Treatment duration
Time frame: Every 6 months up to 3 years
Therapies start and end date
Treatment dose
Time frame: Every 6 months up to 3 years
Dose (e.g. mg)
Treatment frequency
Time frame: Every 6 months up to 3 years
Frequency (e.g. times/day)
9 secondary outcomes
Demographic factors
Time frame: Baseline
Healthcare resource utilization
Time frame: Every 6 months up to 3 years
Cormobidity
Time frame: Every 6 months up to 3 years
Healthcare resource utilization
Time frame: Every 6 months up to 3 years
MG diagnosis history
Time frame: Every 6 months up to 3 years
Vital sign - blood pressure
Time frame: Every 6 months up to 3 years
Laboratory test - blood cell test
Time frame: Every 6 months up to 3 years
Laboratory tests etc.) - MG-related antibodies
Time frame: Every 6 months up to 3 years
Vital sign - pulse
Time frame: Every 6 months up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fudong Shi, MD, PhD principal investigator
Beijing Tiantan Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by AstraZeneca at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: Every 6 months up to 3 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.