Observational Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

What this Trial Is About

Researchers are conducting a multicenter, observational study to describe real-world treatment approaches and clinical outcomes among adults in Russia with generalized myasthenia gravis (gMG) who have acetylcholine receptor (AChR) antibodies. This study aims to characterize the demographic and clinical profiles of these patients while exploring disease severity, hospitalizations, diagnostic pathways, treatments, and outcomes related to myasthenic crises and vaccination practices. The study is non-interventional and follows a single group of about 100 adults across roughly 10 specialized sites. It collects data retrospectively from medical records at baseline and prospectively every six months for up to 36 months. Treatments such as anticholinesterase agents, corticosteroids, immunosuppressants, IVIG, plasmapheresis, thymectomy, rituximab, and complement C5 inhibitors are documented as part of routine clinical care without study-imposed interventions. Participants will have data collected at seven time points, including baseline and follow-ups every six months, with information recorded in an electronic case report form. Researchers will assess measures such as age at diagnosis, clinical symptoms, disease duration, hospitalization rates and durations, scores for disease severity (MG-ADL, QMG, MGFA class), treatment patterns, and vaccination history. There are no study-mandated tests or visits beyond routine care, and the total participation spans up to three years.

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia