NCT04101578

Clinical Prognosis and Progression of Myasthenia Gravis Patients

Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Da, Yuwei, M.D. · Individual
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)	Treatment regimens are determined according to the physician's judgment and preferences of the patients.

Timeline

• Start date: 2017-02-08
• Primary completion: 2023-06-01
• Completion: 2024-12-31
• First posted: 2019-09-24
• Last updated: 2021-08-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study