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

Prior treatment

• Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted).

Other illness

• Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning.

Lab values

• Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity.

Other

• Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance.
• 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.

• 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