Vitaccess Real MG Registry (VRMG)

July 24, 2025 updated by: Vitaccess Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham
        • Contact:
          • Saiju Jacob
          • Phone Number: +44 (0)121 371 2000
        • Principal Investigator:
          • Saiju Jacob, MBBS, MD, DPhil
      • London, United Kingdom, W12 7RZ
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health
        • Principal Investigator:
          • Ali Habib, MD
        • Contact:
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS St. Elizabeth's Hospital
        • Contact:
        • Principal Investigator:
          • Raghav Govindarajan, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • UK HealthCare - University of Kentucky
        • Contact:
          • Research Associate Clinical I/UKHC
          • Phone Number: +1 (859) 323-5000
        • Principal Investigator:
          • Zabeen Mahuwala, MD
    • New Jersey
      • Lumberton, New Jersey, United States, 08048
        • Recruiting
        • Neurology Associates of South Jersey
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University South Carolina
        • Principal Investigator:
          • Katherine Ruzhansky, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Thy Nguyen, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Vitaccess Real MG Registry
Time Frame: 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe change in severity of MG symptoms experienced by patients
Time Frame: At baseline and every 1 month thereafter for up to 10 years.
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.
Describe change in type and severity of fatigue experienced by patients
Time Frame: At baseline and every 2 months thereafter for up to 10 years.
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.
Describe change in type and severity of fatigue experienced by patients
Time Frame: At baseline and every 2 months thereafter for up to 10 years.
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.
Describe change in impact of MG on health-related quality of life of patients
Time Frame: At baseline and every 2 months thereafter for up to 10 years.
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.
Describe the demographic characteristics of patients
Time Frame: At baseline
EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")
At baseline
Describe change in clinical trial participation of patients
Time Frame: At follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Trial Participation Form")
At follow-up visits (every 6±1 months) for up to 10 years
Describe the diagnosis (date, tests, and symptoms) of patients
Time Frame: At baseline
EMR data reported by HCPs or captured via EMR aggregator ("Diagnosis Information Form")
At baseline
Describe change in clinical characteristics of patients.
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Characteristics Form")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in medical history of patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Medical History Form")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in concomitant treatments received by patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Concomitant Medication Log")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in routine MG treatments received by patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Routine MG Treatments Log")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in rescue MG treatments received by patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Rescue MG Treatments Log")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in severity of MG symptoms experienced by patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs or captured via EMR aggregator ("MG-ADL")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in healthcare resource use of patients
Time Frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Healthcare Resource Use")
At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in type and severity of adverse events experienced by patients
Time Frame: At follow-up visits (every 6±1 months) for up to 10 years
EMR data reported by HCPs or captured via EMR aggregator ("Adverse Events")
At follow-up visits (every 6±1 months) for up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitaccess Ltd

Investigators

  • Principal Investigator: Mark JW Larkin, PhD, Vitaccess Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

July 1, 2034

Study Completion (Estimated)

July 1, 2034

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5137-Vitaccess-MG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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