Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®. Study subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 16 week observational study. Study subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits. The primary objective of this observational clinical study is to remotely evaluate MG-specific outcomes using digital health technologies in individuals with gMG during two treatment cycles with VYVGART® or VYVGART Hytrulo®.
Age range
18 Years – 80 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeks
Timeframe: From baseline to 16 weeks.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 16 weeks
Timeframe: From baseline to 16 weeks.
Change in total score of Quality of Life in Neurological Disorders - Fatigue (Neuro-QoL Fatigue) from baseline to 16 weeks
Timeframe: From baseline to 16 weeks. Collected 11 times at home, and once at each clinical visit.
Change in daily walking duration during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant
Timeframe: From baseline to 16 weeks.
Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant
Timeframe: From baseline to week 16.