ClinicalTrials.gg
RecruitingNCT06064461VRMGUpdated Jul 29, 2025

Vitaccess Real MG Registry

An observational study in Myasthenia Gravis, sponsored by Vitaccess Ltd. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Vitaccess Ltd · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 144 studies in Myasthenia Gravis with a site in United States — 53 open to participants now, 73 under way, 25 of them phase 3. Myasthenia Gravis · United States.

Planned enrollment
13th of 36
600 · median 226
Started
2024
with 22 others
Observational
36 of 144
22 open now
Primary completion
2034-07
later than 68 of 72 live
Registered
89th of 144
by date

Among the 144 studies in Myasthenia Gravis with a site in United States, this one is the 13th largest by planned enrollment of the 36 observational ones that give a count, is one of 23 that started in 2024, is one of 36 observational ones, reaches primary completion later than 68 of the 72 other live ones, and was the 89th registered.

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

Browse Myasthenia Gravis studies →

Open to participants now

53 of the 144 studies in Myasthenia Gravis with a site in United States are open now. Recruiting first, the newest first:

48 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 144 studies in Myasthenia Gravis with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Myasthenia Gravis

Browse trials for

Keywords

  • Myasthenia Gravis
  • patient registry
  • longitudinal
  • observational data
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 in their local language to take part in the study.

Exclusion criteria

Exclusion Criteria:

  • Participation in a clinical trial at the time of study enrolment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 10 years

Secondary outcomes

  1. Describe the demographic characteristics of patients

    EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")

    Time frame: At baseline

  2. Describe change in clinical trial participation of patients

    EMR data reported by HCPs or captured via EMR aggregator ("Clinical Trial Participation Form")

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

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

    EMR data reported by HCPs or captured via EMR aggregator ("Diagnosis Information Form")

    Time frame: At baseline

  4. Describe change in clinical characteristics of patients.

    EMR data reported by HCPs or captured via EMR aggregator ("Clinical Characteristics Form")

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

  5. Describe change in medical history of patients

    EMR data reported by HCPs or captured via EMR aggregator ("Medical History Form")

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

  6. Describe change in concomitant treatments received by patients

    EMR data reported by HCPs or captured via EMR aggregator ("Concomitant Medication Log")

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

  7. Describe change in routine MG treatments received by patients

    EMR data reported by HCPs or captured via EMR aggregator ("Routine MG Treatments Log")

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

  8. Describe change in rescue MG treatments received by patients

    EMR data reported by HCPs or captured via EMR aggregator ("Rescue MG Treatments Log")

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

  9. 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")

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

  10. Describe change in healthcare resource use of patients

    EMR data reported by HCPs or captured via EMR aggregator ("Healthcare Resource Use")

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

  11. Describe change in type and severity of adverse events experienced by patients

    EMR data reported by HCPs or captured via EMR aggregator ("Adverse Events")

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

  12. 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")

    Time frame: At baseline and every 1 month thereafter for up to 10 years.

  13. 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")

    Time frame: At baseline and every 2 months thereafter for up to 10 years.

  14. 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")

    Time frame: At baseline and every 2 months thereafter for up to 10 years.

  15. 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")

    Time frame: At baseline and every 2 months thereafter for up to 10 years.

07

Study locations

8 of 8 sites recruiting
  • UCI Health
    Orange, California 92868, United States
    Recruiting
    • Ivonne Turner · Contactimturner@hs.uci.edu · 714-456-7890
    • Ali Habib, MD · Principal investigator
  • HSHS St. Elizabeth's Hospital
    O'Fallon, Illinois 62269, United States
    Recruiting
  • UK HealthCare - University of Kentucky
    Lexington, Kentucky 40536, United States
    Recruiting
    • Research Associate Clinical I/UKHC · Contact+1 (859) 323-5000
    • Zabeen Mahuwala, MD · Principal investigator
  • Neurology Associates of South Jersey
    Lumberton, New Jersey 08048, United States
    Recruiting
  • Medical University South Carolina
    Charleston, South Carolina 29425, United States
    Recruiting
    • Alison Line · Contactline@musc.edu · 843-792-2845
    • Katherine Ruzhansky, MD · Principal investigator
  • 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
    • Saiju Jacob · Contact+44 (0)121 371 2000
    • Saiju Jacob, MBBS, MD, DPhil · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jul 2034, 120 months after the start.

Of 62 observational studies under Myasthenia Gravis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24. This study's planned 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Oct 3, 2023
StartActual
Jul 31, 2024
Primary completionEst.
Jul 2034
CompletionEst.
Jul 2034
Last update
Jul 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06064461
Lead sponsor
Vitaccess Ltd
Responsible party
Sponsor
First posted
Oct 3, 2023
Start date
Jul 31, 2024
Primary completion
Jul 2034 (estimated)
Completion
Jul 2034 (estimated)
Last update
Jul 29, 2025

Study contacts

Mark JW Larkin, PhD
Contact
mark.larkin@vitaccess.com
+44 1865818983
Mark JW Larkin, PhD
principal investigator · Vitaccess Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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