Clinical trial NCT06064461: Vitaccess Real MG Registry
Official title: Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
patient registry
longitudinal
observational data
Lead sponsor: Vitaccess Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Vitaccess Real MG Registry
timeFrame: 10 years
Secondary outcomes:
measure: Describe the demographic characteristics of patients
timeFrame: At baseline
measure: Describe change in clinical trial participation of patients
timeFrame: At follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the diagnosis (date, tests, and symptoms) of patients
timeFrame: At baseline
measure: Describe change in clinical characteristics of patients.
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in medical history of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in concomitant treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in routine MG treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in rescue MG treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in severity of MG symptoms experienced by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in healthcare resource use of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in type and severity of adverse events experienced by patients
timeFrame: At follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in severity of MG symptoms experienced by patients
timeFrame: At baseline and every 1 month thereafter for up to 10 years.
measure: Describe change in type and severity of fatigue experienced by patients
timeFrame: At baseline and every 2 months thereafter for up to 10 years.
measure: Describe change in type and severity of fatigue experienced by patients
timeFrame: At baseline and every 2 months thereafter for up to 10 years.
measure: Describe change in impact of MG on health-related quality of life of patients
timeFrame: At baseline and every 2 months thereafter for up to 10 years.
Other outcomes:
Locations:
city: O'Fallon
country: United States
facility: HSHS St. Elizabeth's Hospital
state: Illinois
city: Lexington
country: United States
facility: UK HealthCare - University of Kentucky
state: Kentucky
city: Lumberton
country: United States
facility: Neurology Associates of South Jersey
state: New Jersey
city: Charleston
country: United States
facility: Medical University South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: London
country: United Kingdom
facility: Vitaccess Ltd
Study officials:
affiliation: Vitaccess Ltd
name: Mark JW Larkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: