Vitaccess Real MG Registry

Traditional site recruitment (all countries):

Adult patients who are being treated for MG at one of the participating clinics or centers in one of the participating countries (currently the US and UK) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.

Patient-reported data will be collected via the VRMG Registry platform, a digital data capture platform accessible via any web-enabled platform (e.g., phone, tablet, laptop, computer). Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of MG on daily living, fatigue, and health-related quality of life.

Site research teams will complete and update an eCRF (every six months ± one months) for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month mark will be considered within the same assessment window for analytics purposes so that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.

Community neurologist recruitment (US only):

Community neurologists who are treating MG patients who would be eligible for participation in the registry will be able to register their interest for involvement and provide details of their credentials via an informational website. Approved community neurologists will identify and approach potential participants, who will participate in the registry as normal. Clinical data will be captured from participants' electronic medical records via an EMR aggregator.

Direct-to-patient recruitment (US only):

A cohort of US-based participants in the MyRealWorld MG study - a longitudinal observational study in MG that Vitaccess has run since 2019 - have provided consent to be contacted by Vitaccess about future research. Vitaccess will contact this patient cohort directly via email to introduce them to the registry; patients can access the registry's informational website to get further information. Clinical data will be captured from participants' electronic medical records via an EMR aggregator.

Patient-reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment.

• Describe the demographic characteristics of patients [Срок оценки: At baseline]
• Describe change in clinical trial participation of patients [Срок оценки: At follow-up visits (every 6±1 months) for up to 10 years]
• Describe the diagnosis (date, tests, and symptoms) of patients [Срок оценки: At baseline]
• Describe change in clinical characteristics of patients. [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in medical history of patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in concomitant treatments received by patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in routine MG treatments received by patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in rescue MG treatments received by patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in severity of MG symptoms experienced by patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in healthcare resource use of patients [Срок оценки: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in type and severity of adverse events experienced by patients [Срок оценки: At follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in severity of MG symptoms experienced by patients [Срок оценки: At baseline and every 1 month thereafter for up to 10 years.]