Vitaccess Real MG Registry

Study Overview
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Brief Summary
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Vitaccess Real MG is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.

Detailed Description
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Adult patients who are being treated for MG at one of the participating clinics or centers in one of the study countries (the US, UK, Germany, France, or Italy) 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 Vitaccess RealTM MG Registry platform, a digital data capture platform accessible via smartphone or tablet (from the Apple or Android app store) or via PC. 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. Patient- and HCP-reported data will be linked via a unique ID and PIN assigned to each participant at enrolment.

Official Title
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Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.

Conditions
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Myasthenia Gravis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age ≥18 years) with a clinically-confirmed diagnosis of myasthenia gravis (MG). Resident in the US, UK, Germany, France, or Italy. Access to a smartphone/tablet/computer/laptop Willing and able to provide informed consent in their local language to take part in the study. Exclusion Criteria: Participation in a clinical trial at the time of study enrolment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Vitaccess Real MG Registry | A patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the demographic characteristics of patients | EMR data reported by HCPs via eCRF (Demographic Information Form) | At baseline | 
| Describe change in clinical trial participation of patients | EMR data reported by HCPs via eCRF (Clinical Trial Participation Form) | At follow-up visits (every 6±1 months) for up to 10 years | 
| Describe the diagnosis (date, tests, and symptoms) of patients | EMR data reported by HCPs via eCRF (Diagnosis Information Form) | At baseline | 
| Describe change in clinical characteristics of patients. | EMR data reported by HCPs via eCRF (Clinical Characteristics Form) | At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years | 
| Describe change in medical history of patients | EMR data reported by HCPs via eCRF (Medical History Form) | 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 | EMR data reported by HCPs via eCRF (Concomitant Medication Log) | 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 | EMR data reported by HCPs via eCRF (Routine MG Treatments Log) | 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 | EMR data reported by HCPs via eCRF (Rescue MG Treatments Log) | 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 | Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs via eCRF (MG-ADL) | 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 | EMR data reported by HCPs via eCRF (Healthcare Resource Use) | 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 | EMR data reported by HCPs via eCRF (Adverse Events) | At follow-up visits (every 6±1 months) for up to 10 years | 
| Describe change in severity of MG symptoms experienced by patients | Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by patients via the Vitaccess Real MG Registry platform (MG-ADL) | At baseline and every 1 month thereafter for up to 10 years. | 
| Describe change in type and severity of fatigue experienced by patients | MG Symptoms PRO Fatigue Component data reported by patients via the Vitaccess Real MG Registry platform (MG Symptoms PRO Fatigue Component) | At baseline and every 2 months thereafter for up to 10 years. | 
| Describe change in type and severity of fatigue experienced by patients | NeuroQoL Fatigue Short Form data reported by patients via the Vitaccess Real MG Registry platform (NeuroQoL Fatigue Short Form) | At baseline and every 2 months thereafter for up to 10 years. | 
| Describe change in impact of MG on health-related quality of life of patients | Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL-15r) data reported by patients via the Vitaccess Real MG Registry platform (MG-QoL-15r) | At baseline and every 2 months thereafter for up to 10 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myasthenia Gravis, patient registry, longitudinal, observational data