Vitaccess Real MG (VRMG) 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. Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.
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.
Study Type
OBSERVATIONAL
Enrollment
600
UCI Health
Orange, California, United States
RECRUITINGHSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States
RECRUITINGUK HealthCare - University of Kentucky
Lexington, Kentucky, United States
RECRUITINGNeurology Associates of South Jersey
Lumberton, New Jersey, United States
RECRUITINGMedical University South Carolina
Charleston, South Carolina, United States
RECRUITINGUniversity of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGVitaccess Ltd
London, London, United Kingdom
RECRUITINGUniversity Hospitals Birmingham
Birmingham, United Kingdom
RECRUITINGThe 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.
Time frame: 10 years
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")
Time frame: At baseline
Describe change in clinical trial participation of patients
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Trial Participation Form")
Time frame: 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 or captured via EMR aggregator ("Diagnosis Information Form")
Time frame: At baseline
Describe change in clinical characteristics of patients.
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Characteristics Form")
Time frame: 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 or captured via EMR aggregator ("Medical History Form")
Time frame: 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 or captured via EMR aggregator ("Concomitant Medication Log")
Time frame: 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 or captured via EMR aggregator ("Routine MG Treatments Log")
Time frame: 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 or captured via EMR aggregator ("Rescue MG Treatments Log")
Time frame: 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 or captured via EMR aggregator ("MG-ADL")
Time frame: 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 or captured via EMR aggregator ("Healthcare Resource Use")
Time frame: 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 or captured via EMR aggregator ("Adverse Events")
Time frame: 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")
Time frame: 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")
Time frame: 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")
Time frame: 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")
Time frame: At baseline and every 2 months thereafter for up to 10 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.