Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | MGFA classification (e.g I, II, III, IV, V) | Every 6 months up to 3 years |
| Treatment method | Targeted treatment methods (list of methods, including medication, immunoglobulin, plasma exchange, surgery etc. ) | 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) | Every 6 months up to 3 years |
| Clinical outcome | MGFA Post-intervention Status (e.g. CSR, PR, MM) | Every 6 months up to 3 years |
| Clinical outcome | Quantitative MG score (QMG, aggregated value in a scale, ranged 0- best to 39-worst) | Every 6 months up to 3 years |
| Clinical outcome | Physician-reported MG crisis | Every 6 months up to 3 years |
| Clinical outcome | Death | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic factors |
| Baseline |
| Healthcare resource utilization | MG-related hospitalization (days) |
Not provided
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:
MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fudong Shi, MD, PhD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China | ||||
| Research Site |
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Every 6 months up to 3 years |
| Patient-reported outcome | EuroQol-5D (separate value for five dimensions in a scale for quality of life) | Every 6 months up to 3 years |
| Treatment duration | Therapies start and end date | Every 6 months up to 3 years |
| Treatment dose | Dose (e.g. mg) | Every 6 months up to 3 years |
| Treatment frequency | Frequency (e.g. times/day) | Every 6 months up to 3 years |
| Every 6 months up to 3 years |
| Cormobidity | Comorbidities (list of related diseases, e.g. autoimmune diseases, cardiovascular disease, hypertension, diabetes etc.) | Every 6 months up to 3 years |
| Healthcare resource utilization | MG-related healthcare costs | Every 6 months up to 3 years |
| MG diagnosis history | MG first time diagnosis date | Every 6 months up to 3 years |
| Vital sign - blood pressure | Blood pressure (mmHg) | Every 6 months up to 3 years |
| Laboratory test - blood cell test | Blood cell counts by cell type tests (e.g. counts/L) | Every 6 months up to 3 years |
| Laboratory tests etc.) - MG-related antibodies | MG-related antibodies including AChR, MuSK, LRP4 etc. (positive or negative). | Every 6 months up to 3 years |
| Vital sign - pulse | Pulse (count/minute) | Every 6 months up to 3 years |
| 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 |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |