Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-01-01 @ 3:59 PM
Study NCT ID:
NCT06877403
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-14
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Disease severity by MG-ADL (from 0 to 24), 0 means no symptom, 24 means severe symptoms. No specific threshold.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Impact of the disease on the daily-life activities by the MG-QoL-15 (from 0 to 60), 0 means no repercussion, 60 means massive repercussion. No specific threshold.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Level of anxiety and depression by HADS (\\< 7 : no symptoms, 8 -11 doubt, \\> 11 symptoms of anxiety and depression)'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. level of physical activity by Godin Leisure Time Activity Questionnaire (\\> 24 : active, 14-23 moderate activity, \\< 14 sedentary)'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Global feeling about the myasthenia by a simple question with the PASS (yes / no)'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic : age in years.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic : weight in kilograms, height in meters, BMI in kg/m2'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic : duration of the disease in years'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic : type of actual or passed treatment : corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Yes or No for each treatment.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic : dosage of actual or passed treatment (corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Dosage in mg per day'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : auto-immune (dysthyroiditis, diabete, lupus, rheumatoid arthritis, other). Yes or No.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : thymectomy. Yes or No.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last myasthenic crisis. Month and years or the year exclusively.'}, {'measure': 'Associated factors with fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last use of crisis treatment (Immunoglobulin, Plasmatic Exchange). Date in month and years or the year exclusively.'}], 'primaryOutcomes': [{'measure': 'Prevalence of fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Determine the prevalence of fatigue in myasthenic patients followed at the Clermont-Ferrand University Hospital by the Fatigue Severity Scale from 1 to 7. 1 = not significative fatigue. 7 = extreme fatigue. Significant if FSS \\> 4.'}], 'secondaryOutcomes': [{'measure': 'Impact of the fatigue', 'timeFrame': 'through study completion, an average of 6 month', 'description': 'Describe the impact of fatigue on daily life by the Modified Fatigue Impact Scale from 21 to 84. 21 = not significative impact of fatigue on daily life, 84 = severe impact of the fatigue. Significant if MFIS \\> 45.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['observationnal', 'fatigue', 'self-questionnaires', 'myasthenia gravis', 'ocular myasthenia gravis', 'generalized myasthenia gravis', 'comorbidities'], 'conditions': ['Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': "After identifying myasthenic patients meeting the inclusion criteria, telephone contact with patients to suggest that they participate in the study by responding to various questionnaires composed of validated scales used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time) which will be completed either digitally (REDCap link) or by paper form if necessary. Consultation of patients' medical records to collect information relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the illness, treatments, etc.).\n\nAs part of their usual care, myasthenia patients answer questionnaires according to the following procedure :\n\n1. Mailing of questionnaires to all eligible patients before their consultation The questionnaires are composed of scales validated and used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time).\n2. Collection of questionnaires When patients come for consultation, the completed questionnaires are collected by the medical team.\n3. Collection of questionnaires The responses to the questionnaires and the scores and results obtained from these questionnaires are integrated into the patients' medical records.\n\nAs part of our study and in parallel with the patient's clinical follow-up, data relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the disease, treatments, etc.) as well as responses to questionnaires will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Myasthenic patients with ocular or generalized form followed in Clermont Ferrand University Hospital (MGFA I to IV)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who consulted the neurology department of the Clermont-Ferrand University Hospital between 01/01/2022 and 12/31/2024 in the context of their myasthenia and identified by the BAMARA and PMSI databases of the Clermont-Ferrand University Hospital\n* Diagnosis of autoimmune myasthenia gravis based on biological and/or electromyographic criteria\n* MGFA class from I to IV\n\nExclusion Criteria:\n\n* Patients under guardianship or curatorship\n* Non-French speaking patients\n* Patients refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT06877403', 'briefTitle': 'Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Prospective Study on the Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia', 'orgStudyIdInfo': {'id': '2025 TAITHE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients suffering from myasthenia gravis (MGFA I to IV) followed in Clermont-Ferrand', 'description': 'Adult patients who consulted the neurology department of the Clermont-Ferrand University Hospital between 01/01/2022 and 12/31/2024 in the context of their myasthenia and identified by the BAMARA and PMSI databases of the Clermont-Ferrand University Hospital Diagnosis of autoimmune myasthenia gravis based on biological and/or electromyographic criteria MGFA class from I to IV'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Frédéric Taithe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}