Observational Study of Real-World Treatments and Outcomes in Adults with AChR Antibody-Positive Generalized Myasthenia Gravis in Russia

What this Trial Is About

Researchers are conducting a multicenter, non-interventional, observational study to understand real-world treatment methods and clinical outcomes in adults living with acetylcholine receptor AChR antibody-positive generalized myasthenia gravis gMG in routine clinical practice in Russia. This study aims to characterize demographic and clinical details of these patients and observe disease severity, hospitalizations, diagnostic approaches, treatment strategies, myasthenic crises, and vaccination use. The study enrolls about 100 adults consecutively across roughly 10 specialized sites. It collects data retrospectively and prospectively from medical records at seven timepoints baseline with retrospective medical history abstraction and follow-ups every six months up to 36 months. No interventions or study-mandated treatments are given, and all patient care follows routine clinical practice. Participants provide informed consent and their existing clinical data are recorded into electronic case report forms. Researchers assess demographics, disease profiles, hospitalizations, treatment patterns including medications and therapies, and vaccination history. Disease severity and clinical status are monitored through standardized scores at baseline and regular intervals. The study spans up to three years, capturing longitudinal data without requiring additional tests or visits beyond routine care.

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