Clinical Trials in the USA / NCT07226830
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Observational
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
NCT07226830 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Myasthenia Gravis Generalized
Study summary
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®.
Eligibility
Inclusion Criteria:
* Diagnosis of autoimmune MG with or without history of thymoma
* MGFA severity class IIa/b, IIIa/b or IVa/b at the screening visit
* Diagnosed gMG through one or more of the following:
* Positive acetylcholine receptor antibody (AChR Ab) test, or
* Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or
* Documented positive response to standard MG therapies (e.g., AChE inhibitors, IVIG/PLEX, FcRn antagonists or C5 inhibitors)
* Currently initiating treatment with VYVGART® or VYVGART Hytrulo®
* Physically and cognitively able to provide informed consent and adhere to the study procedures, as determined by the investigator.
* Ambulatory, defined as the ability to walk at least 10 meters independently, with or without the use of an assistive device.
* Speaks and reads English fluently
Exclusion Criteria:
* 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.
* MGFA severity classification of Class I or Class V (myasthenic crisis). Pregnant or breastfeeding women.
* Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted).
Primary outcome measure(s)
- Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeks — 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 — 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 — From baseline to 16 weeks. Collected 11 times at home, and once at each clinical visit.
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 — From baseline to 16 weeks.
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 daily number of sit to stand transitions (count) during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant — From baseline to week 16.
Daily number of sit to stand transitions 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital, Neuromuscular Diagnostic Center | Boston | Massachusetts |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07226830 on ClinicalTrials.gov ↗ ← All trials in the USA