Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Ali Habib, MD

Description

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.

Official Title

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

Details

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.

Keywords

Myasthenia Gravis, patient registry, longitudinal, observational data

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Participation in a clinical trial at the time of study enrolment.

Locations

  • UCI Health accepting new patients
    Orange California 92868 United States
  • University of Texas Health Science Center at Houston accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UC Irvine

  • Ali Habib, MD
    Health Sciences Professor, Neurology, School of Medicine. Authored (or co-authored) 37 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vitaccess Ltd
ID
NCT06064461
Study Type
Observational
Participants
Expecting 600 study participants
Last Updated