Observational study of Myasthenia Gravis patients in China
A Multicenter, Prospective Cohort Study in Patients With Myasthenia Gravis in China
This study is looking at how Myasthenia Gravis affects patients in China by tracking their health, treatments, and experiences over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 10 sites (Beijing and 9 other locations) |
| Trial ID | NCT06700616 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the clinical practices, patient-reported outcomes, disease prognosis, treatment patterns, and healthcare resource utilization for patients with Myasthenia Gravis (MG) in China. It will enroll approximately 1,200 patients diagnosed with MG from around 40 sites across the country. Participants will be followed up every six months until the end of 2027, with various clinical and patient-reported measures being collected to assess their condition and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients of all ages diagnosed with Myasthenia Gravis of any classification.
Not a fit: Patients with ocular myasthenia gravis lasting more than two years or those currently participating in an interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and treatment of Myasthenia Gravis, potentially improving patient care.
How similar studies have performed: While this study is observational and focuses on characterizing current practices, similar studies have shown success in understanding disease management and improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing and 9 other locations
- Research Site — Beijing, China (Recruiting)
- Research Site — Hebei, China (Recruiting)
- Research Site — Inner Mongolia, China (Recruiting)
- Research Site — Jiangsu, China (Recruiting)
- Research Site — Nanning, China (Recruiting)
- Research Site — Qingdao, China (Recruiting)
- Research Site — Taiyuan, China (Recruiting)
- Research Site — Tianjin, China (Recruiting)
- Research Site — Urumqi, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
Study contacts
- Principal investigator: Fudong Shi, MD, PhD — Beijing Tiantan Hospital
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.