This study collects the clinical data of myasthenia gravis (MG) patients, assesses outcomes and adverse effects of different treatment regimens, and searches for risk factors of conversion to generalized MG.
This is a multicenter, observational cohort trial in the real-world clinical setting recruiting MG patients from Neurology Departments of 6 hospitals in different regions of China. Clinical manifestations, laboratory test results, chest imaging and history of thymectomy are recorded. Patients will be classified by clinical manifestation as well as antibody status, and treatment regimens are determined according to the physician's judgment and preferences of the patients. Patients are followed up prospectively on regular to assess the outcomes of treatments and monitor any side effects. Peripheral blood samples are collected annually. Patients' clinical records are uploaded to an online database. The investigators plan to recruit a final sample of 2000 patients for analysis.
Study Type
OBSERVATIONAL
Enrollment
2,000
Treatment regimens are determined according to the physician's judgment and preferences of the patients.
Xuan Wu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGConversion rates from ocular to generalized MG at the last visit and risk factors.
Ocular MG patients are followed up to determine the ratio of conversion to generalized disease at the end of follow-up. The clinical records will be retrospectively analyzed to search for risk factors of progressing.
Time frame: Baseline, 48 months
Change in Quantitative Myasthenia Gravis (QMG) Scores from Baseline to 48 months.
The QMG is a 13-item scale which measures ocular, bulbar, limb function and respiratory function. The total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) obtained by summing the responses to each individual item (None=0, Mild=1, Moderate=2, Severe=3).
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months
Change in MG-specific Activities of Daily Living scale (MG-ADL).
The MG-ADL is an 8-item scale to assess symptoms of myasthenia gravis patients obtained by summing the responses to each individual item (Grades: 0,1,2,3). The score ranges from 0 to 24.
Time frame: Baseline,3months, 6 months, 9 months, 12 months, 18 months, 24 months, 30months, 36 months, 42 months, 48 months
The proportion of patients reaching minimal manifestations (MM) or better.
Clinical statuses of patients are assessed and categorized according to Myasthenia Gravis Foundation of America (MGFA) postintervention status (PIS). MM or better includes Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR).
Time frame: 48 months
Proportion of Patients with Treatment-related Adverse Experiences.
Treatment-Related Adverse Events (AEs) are evaluated in patients of different regimens.
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
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Changes in titers of MG antibodies.
MG antibodies are detected at enrollment and the titers of antibodies will be monitored annually.
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months