Vitaccess Real MG Registry
ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVitaccess Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (age ≥18 years) with a clinically-confirmed diagnosis of myasthenia gravis (MG).
Resident in one of the scope countries.
Access to a smartphone/tablet/computer/laptop
Willing and able to provide informed consent in their local language to take part in the study.
Disqualifiers
Participation in a clinical trial at the time of study enrolment.
Trial population
Adult patients who are being treated for MG at one of the participating clinics or centers in one of the study countries 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. Adult patients in the US who are not being treated at a participating clinic will be able to enrol via their community neurologist or direct-to-patient recruitment.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
10 yearsSecondary outcomes
1
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")
Time frame
At baseline2
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 years3
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 baseline4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov