Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT06064461
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitaccess Real MG Registry
Sponsor:
Vitaccess Ltd
Organization:
Study Overview
Official Title:
Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRMG
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: