Clinical trial · 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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®.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis Generalized | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- gMG group
- description
- All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities
Primary outcomes (5)
- measure
- 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.
- description
- 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.
- measure
- Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 16 weeks
- timeFrame
- From baseline to 16 weeks.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available