Myasthenia GravisVRMGNCT06064461
Vitaccess Real MG Registry
An observational study of Myasthenia Gravis, run by Vitaccess Ltd at 8 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 600 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 31 Jul 2024to Jul 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participation in a clinical trial at the time of study enrolment.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Medical University South Carolina
Charleston, South Carolina, 29425
Alison Line, 843-792-2845, line@musc.edu
Katherine Ruzhansky, MD
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Christine Farrell, 713-486-0500, christine.m.farrell@uth.tmc.edu
Thy Nguyen, MD
- Recruiting
UK HealthCare - University of Kentucky
Lexington, Kentucky, 40536
Research Associate Clinical I/UKHC, +1 (859) 323-5000
Zabeen Mahuwala, MD
- Recruiting
Neurology Associates of South Jersey
Lumberton, New Jersey, 08048
Mayank Mathur, MD, vrmg@vitaccess.com
- Recruiting
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, 62269
Beth J Corbett, bcorbett@prairieresearch.com
Raghav Govindarajan, MD
- Recruiting
UCI Health
Orange, California, 92868
Ivonne Turner, 714-456-7890, imturner@hs.uci.edu
Ali Habib, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospitals Birmingham
Birmingham, B15 2GW
Saiju Jacob, +44 (0)121 371 2000
Saiju Jacob, MBBS, MD, DPhil
- Recruiting
Vitaccess Ltd
London, London, W12 7RZ
Mark JW Larkin, PhD, +44 1865818983, mark.larkin@vitaccess.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, patient registry, longitudinal, observational data
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (15)
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")
Measured: At baseline
Describe change in clinical trial participation of patients
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Trial Participation Form")
Measured: At follow-up visits (every 6±1 months) for up to 10 years
Describe the diagnosis (date, tests, and symptoms) of patients
EMR data reported by HCPs or captured via EMR aggregator ("Diagnosis Information Form")
Measured: At baseline
Describe change in clinical characteristics of patients.
EMR data reported by HCPs or captured via EMR aggregator ("Clinical Characteristics Form")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe change in medical history of patients
EMR data reported by HCPs or captured via EMR aggregator ("Medical History Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregator ("Concomitant Medication Log")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregator ("Routine MG Treatments Log")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregator ("Rescue MG Treatments Log")
Measured: 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
Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs or captured via EMR aggregator ("MG-ADL")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregator ("Healthcare Resource Use")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregator ("Adverse Events")
Measured: At follow-up visits (every 6±1 months) for up to 10 years
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")
Measured: At baseline and every 1 month thereafter for up to 10 years.
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")
Measured: At baseline and every 2 months thereafter for up to 10 years.
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")
Measured: 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
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")
Measured: At baseline and every 2 months thereafter for up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start31 Jul 2024
- Primary completionJul 2034 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitaccess Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark JW Larkin, PhD, Principal investigator, Vitaccess Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064461
- Sponsor's protocol ID
- 5137-Vitaccess-MG-01
- Acronym
- VRMG
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.
- ClinicalTrials.gov ID
- NCT06064461
- Acronym / sponsor ID
- VRMG / 5137-Vitaccess-MG-01
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, patient registry, longitudinal, observational data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Vitaccess LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jul 2034 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in a clinical trial at the time of study enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
Describe the demographic characteristics of patients
Time frame: 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
Describe the diagnosis (date, tests, and symptoms) of patients
Time frame: 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
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
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
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
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
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
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
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
Describe change in severity of MG symptoms experienced by patients
Time frame: 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark JW Larkin, PhD principal investigator
Vitaccess Ltd
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Vitaccess Ltd at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark JW Larkin, PhD (+44 1865818983, mark.larkin@vitaccess.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Vitaccess Real MG Registry (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.