Vitaccess Real MG Registry

Myasthenia Gravis Clinical Trial

— VRMG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06064461
• Other study ID #: 5137-Vitaccess-MG-01
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2034

Study information

• Verified date: January 2024
• Source: Vitaccess Ltd
• Contact: Mark JW Larkin, PhD
• Phone: +44 1865818983
• Email: mark.larkin[@]vitaccess.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 2034
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myasthenia Gravis

Locations

Country	Name	City	State
United Kingdom	Vitaccess Ltd	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Vitaccess Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years
Secondary	Describe the demographic characteristics of patients	EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")	At baseline
Secondary	Describe change in clinical trial participation of patients	EMR data reported by HCPs or captured via EMR aggregators ("Clinical Trial Participation Form")	At follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe the diagnosis (date, tests, and symptoms) of patients	EMR data reported by HCPs or captured via EMR aggregators ("Diagnosis Information Form")	At baseline
Secondary	Describe change in clinical characteristics of patients.	EMR data reported by HCPs or captured via EMR aggregators ("Clinical Characteristics Form")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in medical history of patients	EMR data reported by HCPs or captured via EMR aggregators ("Medical History Form")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in concomitant treatments received by patients	EMR data reported by HCPs or captured via EMR aggregators ("Concomitant Medication Log")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in routine MG treatments received by patients	EMR data reported by HCPs or captured via EMR aggregators ("Routine MG Treatments Log")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in rescue MG treatments received by patients	EMR data reported by HCPs or captured via EMR aggregators ("Rescue MG Treatments Log")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	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 aggregators ("MG-ADL")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in healthcare resource use of patients	EMR data reported by HCPs or captured via EMR aggregators ("Healthcare Resource Use")	At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Secondary	Describe change in type and severity of adverse events experienced by patients	EMR data reported by HCPs or captured via EMR aggregators ("Adverse Events")	At follow-up visits (every 6±1 months) for up to 10 years
Secondary	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")	At baseline and every 1 month thereafter for up to 10 years.
Secondary	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")	At baseline and every 2 months thereafter for up to 10 years.
Secondary	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")	At baseline and every 2 months thereafter for up to 10 years.
Secondary	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")	At baseline and every 2 months thereafter for up to 10 years.