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®.
Diagnosis of autoimmune MG with or without history of thymoma
MGFA severity class IIa/b, IIIa/b or IVa/b at the screening visit
Positive acetylcholine receptor antibody (AChR Ab) test, or
Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or
Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance.
Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning.
Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity.
Current residence in a long-term care or institutional facility (e.g., nursing home, skilled nursing facility), receipt of hospice care, or incarceration.
Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b who are initiating treatment with VYVGART® or VYVGART Hytrulo®
Cohort
Prospective
Not listed
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeks
Scores for the MG-ADL range from 0-24. A lower score represents a better outcome and a higher score is a worse outcome. Collected 11 times at home, and once at each clinical visit.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 16 weeks
Scores for the MGQoL-15R range from 0-30. A lower score represents a better outcome and a higher score is a worse outcome. Collected 11 times at home, and once at each clinical visit.
Change in total score of Quality of Life in Neurological Disorders - Fatigue (Neuro-QoL Fatigue) from baseline to 16 weeks
Scores for the Neuro-QoL Fatigue range from 8-40. A lower score represents a better outcome and a higher score is a worse outcome.
Change in daily walking duration during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant
Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, Visit 2 (approximately week 8) , and Visit 3 (approximately week 16)
Change in intelligibility when reading a standard Rainbow passage from baseline to 16 weeks as measured by BioDigit Speech
Speech data will be collected from participants while reading a standard Rainbow passage. Speech data will be collected 11 times using the at-home platform. Speech data will also be collected at each clinical visit. BioDigit Speech, an automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.
Change in Marginal Reflex Distance-1 during the upward gaze test as measured by BioDigit Video from baseline to 16 weeks
Video data will be collected from participants while performing a standard upward gaze test. Video data will be collected 11 times using the at-home platform. Video data will also be collected at each clinical visit. BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate Marginal Reflex Distance-1 during the upward gaze test.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 16 weeks
Scores for the MGC range from 0-50. A lower score represents a better outcome and a higher score is a worse outcome. Collected once at each clinical visit.
Change in total score of the Quantitative Myasthenia Gravis (QMG) scale from baseline to 16 weeks
Scores for the QMG range from 0-39. A lower score represents a better outcome and a higher score is a worse outcome. Collected once at each clinical visit.
Change in daily mean heart rate (beats per minute or BPM) during activities of daily living from baseline to 16 weeks as measured by the Samsung Galaxy watch
Heart rate will be measured during activities of daily living using the Samsung Galaxy watch. Samsung Galaxy watch will be worn continuously from 1 week prior to baseline until the end of study visit.
Change in forced vital capacity during a standard spirometer breathing test from baseline to 16 weeks as measured by a FDA-listed spirometer
Forced vital capacity (FVC) will be measured directly by the spirometer during a standard breathing assessment. The FVC will be measured in Litres. FVC will be collected 11 times at home, and once at each clinical visit.
Change in mean articulatory rate when reading a standard Rainbow passage from baseline to 16 weeks as measured by BioDigit Speech
Speech data will be collected from participants while reading a standard Rainbow passage. Speech data will be collected 11 times using the at-home platform. Speech data will also be collected at each clinical visit. BioDigit Speech, an automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.
Change in mean eye aspect ratio during the upward gaze test as measured by BioDigit Video from baseline to 16 weeks
Video data will be collected from participants while performing a standard upward gaze test. Video data will be collected 11 times using the at-home platform. Video data will also be collected at each clinical visit. BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate eye aspect ratio during the upward gaze test.
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BioSensics
Lead sponsor
Massachusetts General Hospital
Collaborator
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