Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-07-31
2034-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vitaccess Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Mark JW Larkin, PhD
Role: PRINCIPAL_INVESTIGATOR
Vitaccess Ltd
Locations
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UCI Health
Orange, California, United States
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States
UK HealthCare - University of Kentucky
Lexington, Kentucky, United States
Neurology Associates of South Jersey
Lumberton, New Jersey, United States
Medical University South Carolina
Charleston, South Carolina, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Vitaccess Ltd
London, London, United Kingdom
University Hospitals Birmingham
Birmingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Research Associate Clinical I/UKHC
Role: primary
Saiju Jacob
Role: primary
Other Identifiers
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5137-Vitaccess-MG-01
Identifier Type: -
Identifier Source: org_study_id
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