Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT06064461
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitaccess Real MG Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2034-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Vitaccess Real MG Registry', 'timeFrame': '10 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Describe the demographic characteristics of patients', 'timeFrame': 'At baseline', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Registration Form")'}, {'measure': 'Describe change in clinical trial participation of patients', 'timeFrame': 'At follow-up visits (every 6±1 months) for up to 10 years', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Clinical Trial Participation Form")'}, {'measure': 'Describe the diagnosis (date, tests, and symptoms) of patients', 'timeFrame': 'At baseline', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Diagnosis Information Form")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Clinical Characteristics Form")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Medical History Form")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Concomitant Medication Log")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Routine MG Treatments Log")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Rescue MG Treatments Log")'}, {'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', 'description': 'Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs or captured via EMR aggregator ("MG-ADL")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Healthcare Resource Use")'}, {'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', 'description': 'EMR data reported by HCPs or captured via EMR aggregator ("Adverse Events")'}, {'measure': 'Describe change in severity of MG symptoms experienced by patients', 'timeFrame': 'At baseline and every 1 month thereafter for up to 10 years.', 'description': 'Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by patients via the Vitaccess Real MG Registry platform ("MG-ADL")'}, {'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.', 'description': 'MG Symptoms PRO Fatigue Component data reported by patients via the Vitaccess Real MG Registry platform ("MG Symptoms PRO Fatigue Component")'}, {'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.', 'description': 'NeuroQoL Fatigue Short Form data reported by patients via the Vitaccess Real MG Registry platform ("NeuroQoL Fatigue Short Form")'}, {'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.', 'description': '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")'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'patient registry', 'longitudinal', 'observational data'], 'conditions': ['Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.', 'detailedDescription': "Traditional site recruitment (all countries):\n\nAdult 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.\n\nPatient-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.\n\nSite 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.\n\nCommunity neurologist recruitment (US only):\n\nCommunity 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.\n\nDirect-to-patient recruitment (US only):\n\nA 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.\n\nPatient-reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nAdult 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age ≥18 years) with a clinically-confirmed diagnosis of myasthenia gravis (MG).\n* Resident in one of the scope countries.\n* Access to a smartphone/tablet/computer/laptop\n* Willing and able to provide informed consent in their local language to take part in the study.\n\nExclusion Criteria:\n\n* Participation in a clinical trial at the time of study enrolment.'}, 'identificationModule': {'nctId': 'NCT06064461', 'acronym': 'VRMG', 'briefTitle': 'Vitaccess Real MG Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitaccess Ltd'}, 'officialTitle': 'Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.', 'orgStudyIdInfo': {'id': '5137-Vitaccess-MG-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ivonne Turner', 'role': 'CONTACT', 'email': 'imturner@hs.uci.edu', 'phone': '714-456-7890'}, {'name': 'Ali Habib, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCI Health', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beth J Corbett', 'role': 'CONTACT', 'email': 'bcorbett@prairieresearch.com'}, {'name': 'Raghav Govindarajan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "HSHS St. Elizabeth's Hospital", 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Associate Clinical I/UKHC', 'role': 'CONTACT', 'phone': '+1 (859) 323-5000'}, {'name': 'Zabeen Mahuwala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UK HealthCare - University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '08048', 'city': 'Lumberton', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mayank Mathur, MD', 'role': 'CONTACT', 'email': 'vrmg@vitaccess.com'}], 'facility': 'Neurology Associates of South Jersey', 'geoPoint': {'lat': 39.96595, 'lon': -74.80516}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Line', 'role': 'CONTACT', 'email': 'line@musc.edu', 'phone': '843-792-2845'}, {'name': 'Katherine Ruzhansky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Farrell', 'role': 'CONTACT', 'email': 'christine.m.farrell@uth.tmc.edu', 'phone': '713-486-0500'}, {'name': 'Thy Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'W12 7RZ', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mark JW Larkin, PhD', 'role': 'CONTACT', 'email': 'mark.larkin@vitaccess.com', 'phone': '+44 1865818983'}], 'facility': 'Vitaccess Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'B15 2GW', 'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Saiju Jacob', 'role': 'CONTACT', 'phone': '+44 (0)121 371 2000'}, {'name': 'Saiju Jacob, MBBS, MD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Mark JW Larkin, PhD', 'role': 'CONTACT', 'email': 'mark.larkin@vitaccess.com', 'phone': '+44 1865818983'}], 'overallOfficials': [{'name': 'Mark JW Larkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vitaccess Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitaccess Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}