Vitaccess Real MG Registry

Trial Title: Vitaccess Real MG Registry

NCT ID: NCT06064461

Condition: Myasthenia Gravis

Conditions: Official terms:
Myasthenia Gravis

Conditions: Keywords:
Myasthenia Gravis
patient registry
longitudinal
observational data

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

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 (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 VRMG 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. 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. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs. 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. Patients will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs. Patient-reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment.

Criteria for eligibility:

Study pop:
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. 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.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: HSHS St. Elizabeth's Hospital

Address:
City: O'Fallon
Zip: 62269
Country: United States

Status: Recruiting

Contact:
Last name: Beth J Corbett
Email: bcorbett@prairieresearch.com

Investigator:
Last name: Raghav Govindarajan, MD
Email: Principal Investigator

Facility:
Name: Vitaccess Ltd

Address:
City: London
Zip: W12 7RZ
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Mark JW Larkin, PhD

Phone: +44 1865818983
Email: mark.larkin@vitaccess.com

Start date: July 31, 2024

Completion date: July 2034

Lead sponsor:
Agency: Vitaccess Ltd
Agency class: Industry

Source: Vitaccess Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06064461