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Observational Study of VYVGART® and VYVGART Hytrulo® in Generalized Myasthenia Gravis

This observational study is looking at how well digital health tools can track changes in symptoms for people with generalized myasthenia gravis (gMG) who are starting treatment with VYVGART® or VYVGART Hytrulo®. Researchers want to see if these tools can provide a more complete picture of how gMG affects daily life compared to traditional clinic visits. You might be able to join if you are 18 to 80 years old, have a diagnosis of gMG (confirmed by positive acetylcholine receptor antibody test or abnormal nerve tests), and have a certain level of disease severity. The study will measure changes in your daily activities, quality of life, and fatigue over 16 weeks. The study status is unclear, and it plans to enroll 25 participants.

Study design
This is an observational study, meaning researchers will monitor participants without assigning specific treatments. It plans to enroll 25 participants.
What's involved
You will wear multiple wearable sensors to track physical activity and other data daily. You will also complete speech, video, and digital assessments at home and during study visits over 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be monitored for 16 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226830

Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG

Not Yet Recruiting
Not specifiedAges 18–80Observational
BioSensics
~25 participants
Updated 2025-11-12 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeks
Measured over From baseline to 16 weeks.
+4 more outcomes measured

Conditions

Myasthenia Gravis Generalized

Explore related trials

Myasthenia GravisAcetylcholine Receptor

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Ashkan Vaziri, PhD
[email protected]
8885896213
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeksFrom 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 weeksFrom 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 weeksFrom 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 pendantFrom 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 pendantFrom 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).