Vitaccess Real MG Registry

NCT06064461 | Recruiting

• 1 other identifier: 5137-Vitaccess-MG-01
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 8

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.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; patient registry; longitudinal; observational data

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Describe the demographic characteristics of patients

  At baseline

• Describe change in clinical trial participation of patients

  At follow-up visits (every 6±1 months) for up to 10 years

• Describe the diagnosis (date, tests, and symptoms) of patients

  At baseline

• Describe change in clinical characteristics of patients.

  At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years

• Describe change in medical history of patients

  At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Vitaccess Ltd: lead

Study Sites (8)

UCI Health

Orange, California, 92868, United States

RECRUITING

HSHS St. Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

UK HealthCare - University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Neurology Associates of South Jersey

Lumberton, New Jersey, 08048, United States

RECRUITING

Medical University South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Vitaccess Ltd

London, London, W12 7RZ, United Kingdom

RECRUITING

University Hospitals Birmingham

Birmingham, B15 2GW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark JW Larkin, PhD

  Vitaccess Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark JW Larkin, PhD

CONTACT

+44 1865818983; mark.larkin@vitaccess.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: July 31, 2024
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (6)