Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT06006832
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study of Myasthenia Gravis in China
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood of each participant at each visit.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse of myasthenia gravis', 'timeFrame': 'Within two years after recruitment', 'description': 'One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.'}], 'secondaryOutcomes': [{'measure': 'Time of relapse', 'timeFrame': 'Within two years after recruitment', 'description': 'The time between recruitment and relapse of MG.'}, {'measure': 'Change of MG assessment scales at relapse', 'timeFrame': 'Within two years after recruitment', 'description': 'Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite).'}, {'measure': 'Adverse events of steroids', 'timeFrame': 'Within two years after recruitment', 'description': 'Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:\n\n1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.\n2. To identify potential biomarkers that can predict disease progression and prognosis.\n\nThis study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.\n* 2: Diagnosed as myasthenia gravis.\n* 3: Follow-up time at PUMCH\\>6 months.\n* 4: The patient understood and signed the informed consent form.\n\nExclusion Criteria:\n\n* 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess\n* 2: Records related to comorbidities and medications were not available at baseline and during follow-up.'}, 'identificationModule': {'nctId': 'NCT06006832', 'briefTitle': 'A Prospective Cohort Study of Myasthenia Gravis in China', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China', 'orgStudyIdInfo': {'id': 'K2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'maintenance steroid therapy group', 'description': 'Maintaining low-dose oral steroids', 'interventionNames': ['Drug: Steroid Drug']}, {'label': 'immunosuppresants withdrawal group', 'description': 'Withdraw all immunosuppresants', 'interventionNames': ['Other: Withdraw all immunosuppresants']}], 'interventions': [{'name': 'Steroid Drug', 'type': 'DRUG', 'description': 'Maintaining low-dose oral steroids', 'armGroupLabels': ['maintenance steroid therapy group']}, {'name': 'Withdraw all immunosuppresants', 'type': 'OTHER', 'description': 'Withdraw all immunosuppresants', 'armGroupLabels': ['immunosuppresants withdrawal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Peng', 'role': 'CONTACT', 'email': 'pumchkyc@163.com', 'phone': '8610-69155817'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuzhou Guan', 'role': 'CONTACT', 'email': 'guanyz001@163.com', 'phone': '8610-69155817'}], 'overallOfficials': [{'name': 'Yuzhou Guan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}