What this study is
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®.
Study details
- Sponsor
- BioSensics
- Conditions
- Myasthenia Gravis Generalized
- Enrolling
- 25 people
- Starts
- 2027-03-15
- Est. completion
- 2028-03-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital, Neuromuscular Diagnostic Center
Boston, Massachusetts, United States
- Amanda Guidon, MD MPH · Contact617-726-3642aguidon@mgb.org
Study team
Sponsor
BioSensics
Study ID BioDigit MG-03
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.