[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myasthenia-gravis-generalized\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myasthenia-gravis-generalized":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,42,70,93,117,208,230,255,275,297,317,336,361,387,406,442],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631516","phase-2-a-phase-2-study-to-evaluate-povetacicept-in-adults-with-generalized-myasthenia-gravis-100631516",false,"NCT07501702","A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis","ETNA","Key Inclusion Criteria:\n\n* Age 18-80 years\n* Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV\n* Additional inclusion criteria are defined in the protocol\n\nKey Exclusion Criteria:\n\n* History of thymic surgery within 6 months of screening\n* History of malignancy within the last 5 years\n* Additional exclusion criteria are defined in the protocol\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.","ALL","18 Years","80 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).",[28],"Myasthenia Gravis, Generalized","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2026-05-13",{"date":37,"type":22},"2029-03-02",{"name":39,"class":40},"Vertex Pharmaceuticals Incorporated","INDUSTRY",17,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100585967","ravulizumab-treatment-outcomes-in-patients-with-generalized-myasthenia-gravis-100585967","NCT06909253","Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis","Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (gMG) Naive to Complement Inhibitors. Prospective, Multicenter, Non-interventional Study (MG-ARCADIA).","MG-ARCADIA","Inclusion Criteria:\n\n* Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment in the frames of NDP in Poland.\n* Patients willing to participate in the study and signed Informed Consent Form (ICF).\n* Vaccination against N. meningitidis\n\nExclusion Criteria:\n\n* Those who plan to participate in gMG clinical trial on\u002Fafter the date of first ravulizumab infusion through NDP.\n* Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.",{"count":51,"type":22},50,"OBSERVATIONAL","The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that received ravulizumab.",[28],[56,57,58,59],"Ravulizumab","Generalized Myasthenia Gravis","gMG","observational","2026-06-17",{"date":62,"type":33},"2026-06-18",{"date":64,"type":33},"2025-05-15",{"date":66,"type":22},"2029-12-31",{"name":68,"class":40},"AstraZeneca",12,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100642475","phase-3-a-phase-3-study-to-evaluate-claseprubart-in-adults-with-generalized-myasthenia-gravis-emerge-100642475","NCT07647510","A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)","A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out\n2. Weight range between 40-130 kg at Screening\n3. Diagnosis of gMG by the following tests:\n\n   1. Acetylcholine receptor antibody (AChR Ab) positive, and\n   2. One of the following:\n\n   i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.\n4. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa\n5. MG-ADL scale score of 6 or more\n6. QMG scale score of 10 or more\n7. Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability\n8. Female participants must be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception\n9. Male participants agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception\n\nExclusion Criteria:\n\n1. History or presence of significant medical\u002Fsurgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety\u002Fefficacy or study procedures\n2. Known complement deficiency\n3. Prior history (at any time) of N. meningitidis infection\n4. Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening\n5. Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. \\[\n6. Any thymic surgery\u002Fbiopsy within 1 year of Screening\n7. Any known or untreated thymoma.\n8. Any history of thymic carcinoma or thymic malignancy\n9. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone\n10. Concurrent or previous use of the following medication within the time periods specified below.\n\n    1. Rituximab or other B-cell targeting therapies (ie, inebilizumab) within 6 months (180 days) prior to randomization (Day 1);\n    2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1)\n11. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent\n12. Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE",{"count":78,"type":22},195,[80],"PHASE3","The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).",[28],"NOT_YET_RECRUITING","2026-06-09",{"date":86,"type":33},"2026-06-15",{"date":88,"type":22},"2026-07",{"date":90,"type":22},"2031-09",{"name":92,"class":40},"Dianthus Therapeutics",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":116},"100637137","phase-1-study-of-aritinercept-in-patients-with-generalized-myasthenia-gravis-100637137","NCT07596901","Study of Aritinercept in Patients With Generalized Myasthenia Gravis","A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF\u002FAPRIL Inhibitor, in Patients With Generalized Myasthenia Gravis","Key Inclusion Criteria:\n\n* Adult patients (18-85 years old)\n* Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG\n* Additional inclusion criteria are defined in the protocol\n\nKey Exclusion Criteria:\n\n* Current or medical history of malignancy within the last 5 years\n* Pregnant, breastfeeding or intending to become pregnant during the Study\n* Additional exclusion criteria are defined in the protocol","85 Years",{"count":102,"type":22},81,[104,25],"PHASE1","This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.",[28],[108],"aritinercept",{"date":110,"type":33},"2026-05-19",{"date":112,"type":33},"2026-04-22",{"date":37,"type":22},{"name":115,"class":40},"Aurinia Pharmaceuticals Inc.",3,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":52,"phases":4,"briefSummary":129,"conditions":130,"keywords":174,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":207},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform",true,"2 Years",{"count":127,"type":22},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,28,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[151,175,176,177,178,179,180,181,182,183,132,184,185,186,187,188,153,189,190,191,192,193,194,195,196],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":199,"type":33},"2026-01-22",{"date":201,"type":33},"2023-07-05",{"date":203,"type":22},"2030-12-31",{"name":205,"class":206},"Brain Inflammation Collaborative","OTHER",1,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100617799","holistic-assessment-and-remote-digital-monitoring-of-myasthenia-gravis-via-myosense-360-100617799","NCT07323316","Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360","HARMONY 360","Inclusion Criteria:\n\n* Age ≥ 18 years at screening\n* Patients with gMG diagnosis confirmed by the investigator based at least on one of the following:\n* Positive antibody testing for ACHR or MuSK antibodies; or,\n\n  * LRP-4 antibodies or seronegative patients with additional positive single fiber examination; or,\n  * Abnormal single-fiber EMG (SFEMG) jitter in at least one clinically weak muscle; or,\n  * Objective evidence of improvement of clinical gMG symptoms following treatment with oral AChEI or positive pyridostigmine or neostigmine or edrophonium test\n* MGFA Class IIa to IVb\n* Having read the information sheet and signed the informed consent form\n* Owning and able to use a personal smartphone which software version is above 16 for iOS and 8 for Android included\n* Able to read languages in which the mobile application is available and able to understand pictograms (MyoSense 360 is available in local official languages)\n* Able to use an activity monitor (per Actigraph LEAP activity monitor wearability criteria; see vendor guidance)\n* For France only, affiliated with or benefiting from a social security system\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.\n* Person under guardianship or curatorship\n* Current drugs or\u002Fand alcohol abuse that could influence performance on the tests, as judged by the investigator\n* Participant has participated in another interventional clinical study within 30 days prior to screening or who are currently enrolled in another study that, in the - Investigator's opinion, could interfere with their full participation in this study or confound the assessment of the subject or study outcomes\n* For France only, participant who has received more than €6,000 in compensation over the past 12 months for participating in human research, clinical trials, clinical investigations or performance studies.",{"count":216,"type":22},100,[218],"NA","The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study.\n\nThe primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +\u002F- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening\u002Fexacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.",[28],"2025-12-29",{"date":223,"type":33},"2026-01-07",{"date":225,"type":22},"2026-04",{"date":227,"type":22},"2027-10",{"name":229,"class":206},"Ad scientiam",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":237,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":207},"100610380","quantification-of-change-in-mg-disease-activity-in-individuals-with-generalized-myasthenia-gravis-gmg-after-administration-of-vyvgart-or-vyvgart-hytrulo-using-biodigit-mg-100610380","NCT07226830","Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG","BioDigit MG-03","Inclusion Criteria:\n\n* Diagnosis of autoimmune MG with or without history of thymoma\n* MGFA severity class IIa\u002Fb, IIIa\u002Fb or IVa\u002Fb at the screening visit\n* Diagnosed gMG through one or more of the following:\n* Positive acetylcholine receptor antibody (AChR Ab) test, or\n* Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or\n* Documented positive response to standard MG therapies (e.g., AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors)\n* Currently initiating treatment with VYVGART® or VYVGART Hytrulo®\n* Physically and cognitively able to provide informed consent and adhere to the study procedures, as determined by the investigator.\n* Ambulatory, defined as the ability to walk at least 10 meters independently, with or without the use of an assistive device.\n* Speaks and reads English fluently\n\nExclusion Criteria:\n\n* Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance.\n* Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning.\n* Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity.\n* Current residence in a long-term care or institutional facility (e.g., nursing home, skilled nursing facility), receipt of hospice care, or incarceration.\n* MGFA severity classification of Class I or Class V (myasthenic crisis). Pregnant or breastfeeding women.\n* Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted).",{"count":238,"type":22},25,"Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®.\n\nStudy subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 16 week observational study.\n\nStudy subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits.\n\nThe primary objective of this observational clinical study is to remotely evaluate MG-specific outcomes using digital health technologies in individuals with gMG during two treatment cycles with VYVGART® or VYVGART Hytrulo®.",[241],"Myasthenia Gravis Generalized",[243,244,245],"myasthenia gravis","digital health","wearable sensors","2025-11-09",{"date":248,"type":33},"2025-11-12",{"date":250,"type":22},"2026-01-15",{"date":252,"type":22},"2028-03-31",{"name":254,"class":40},"BioSensics",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":262,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":207},"100610192","multi-modal-monitoring-of-disease-symptoms-in-myasthenia-gravis-100610192","NCT07224386","Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis","BioDigit MG-02","Inclusion Criteria:\n\n* Autoimmune MG with or without history of thymoma, MGFA severity Class IIa\u002Fb, IIIa\u002Fb or IVa\u002Fb at the screening visit\n* Diagnosed gMG through ONE of the following methods:\n\n  * Positive acetylcholine receptor antibody (AChR Ab) test\n  * Positive muscle specific kinase receptor antibody (MuSK Ab) test\n  * Positive LRP4 antibody and abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors\n  * Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors.\n* Physically and cognitively able to provide informed consent and adhere to the protocol, as determined by the investigator's judgment\n* Ambulatory status defined as the ability to walk a distance of 10 meters independently, with or without the use of an assistive device\n* Male or female, between the ages of 18 years old and 80 years old\n* Speaks and reads English fluently\n\nExclusion Criteria:\n\n* Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, or eating independently.\n* Neurological or orthopedic problems independent of myasthenia which significantly affect gait and ADLs in the investigator's judgement.\n* Any significant medical, laboratory, or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study.\n* Residence in long-term care centers or institutions, nursing facilities, skilled nursing facilities, or recipients of hospice care, or incarceration.\n* MGFA severity class I or V (MG crisis)\n* Pregnant women.\n* Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)",{"count":51,"type":22},"Evaluate the feasibility of using digital health technologies to monitor symptoms in myasthenia gravis (MG).\n\nStudy subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 12 month observational study. Study subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits.\n\nThe primary objective for this observational study is to measure the correlation of sensor-derived measures of physical activity to MG-specific ratings of MG-ADL, QMG, MGC, and Neuro-QoL Fatigue",[265,28],"Myasthenia Gravis",[243,244,245],"2025-10-31",{"date":269,"type":33},"2025-11-04",{"date":271,"type":22},"2026-01-01",{"date":273,"type":22},"2028-04-30",{"name":254,"class":40},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":207},"100598553","phase-4-evaluate-the-benefit-of-corticoid-sparing-in-elderly-with-generalized-antirach-myasthenia-gravis-treated-with-iv-or-sc-efgartigimod-100598553","NCT07072988","Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod","A Multicenter, Prospective, Observational, Open-label Study to Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod","OPTIMAGE","Inclusion Criteria:\n\n* Male or female subjects aged ≥65 years\n* Diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed seropositivity for AChR-Abs.\n* Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class IIa, Iib, IIIa, IIIb.\n* Patient suitable for efgartigimod treatment\n* MG-ADL score ≥ 2\n* Treated with high (\\>50mg\u002Fdaily) or intermediate (20-50mg\u002Fdaily) dose of oral corticosteroids (prednisone or prednisolone) and in stable dose of concomitant treatments for at least three months (changes of anticholinesterase therapy are permitted).\n* Patient that has developed at least one of the following iatrogenic comorbidities after the introduction of intermediate or high dose of oral corticosteroids: type 2 diabetes; arterial hypertension; overweight; sleep disorders; irritability and\u002For Patient experiencing a documented worsening of at least one of the following comorbidities after the introduction of intermediate or high dose of corticosteroids, including type 2 diabetes; arterial hypertension; overweight; sleep disorders; irritability\n* Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent\n* Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures\n* Patient affiliated to a European social security system\n\nExclusion Criteria:\n\n* Any current mental condition (psychiatric disorder, senility, or dementia) that, in the opinion of the investigator, may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study; and\u002For patient with a Mini-mental State Examination (MMSE) \\\u003C28.\n* History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.\n* Ongoing malignancy including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured)\n* Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening\n* Vaccination with live or live-attenuated vaccines within the 6 weeks\n* Patient already treated with anti-complement (wash-out period 3 months) or anti-FcRN (wash-out period 3 months), anti-CD20 (wash-out period 6 months) and PLEX (wash-out period 1 month)\n* Patient with end-stage disease or with a disease that will enable him to be evaluated and\u002For treated\n* Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code.","65 Years",{"count":51,"type":22},[286],"PHASE4","Generalized Myasthenia Gravis (gMG) is a rare chronic autoimmune disorder causing muscle weakness and fatigue, primarily due to autoantibodies that disrupt neuromuscular junction function. The most common antibodies target nicotinic acetylcholine receptors (AChR), with others such as anti-MuSK and anti-LRP4 being less prevalent. The conventional gMG treatments include acetylcholinesterase inhibitors, corticosteroids, immunosuppressant and, in case of myasthenic crisis, plasma exchange (PLEX) and intravenous immunoglobulins (IVIG). Treatment aims to achieve minimal manifestation status (MMS), but many patients face persistent symptoms or side effects. Corticosteroids, while effective, carry significant risks, especially for long-term use, such as, increased infection and cardiovascular risks, chronic conditions like hypertension, diabetes, and osteoporosis and quality of life impacts, including weight gain and mood changes. Elderly patients, who form the majority of the gMG population, are particularly vulnerable due to age-related comorbidities, which limit treatment options and prolong corticosteroid reliance. This contributes to increased mortality, disability, and dependency. Efgartigimod (EFG), a novel therapeutic targeting the neonatal Fc receptor (FcRn), accelerates degradation of pathogenic IgG antibodies, including anti-AChR. Clinical trials demonstrated its efficacy and safety in reducing antibody levels, improving muscle strength, and enhancing quality of life. Both intravenous (IV) and subcutaneous (SC) forms are effective and well tolerated. Approved in the United States and subsequently in Japan and Europe, EFG became available in France in 2023. The present multicenter observational study aims to evaluate the real-life impact of EFG in elderly gMG patients struggling with corticosteroid side effects or comorbidity exacerbations. The objectives of this study include the assessing EFG's ability to enable corticosteroid reduction and monitoring improvements in gMG symptoms, quality of life, comorbidities, and overall health.\n\nThis approach highlights a shift towards targeted therapies that balance efficacy with reduced treatment-related burdens for vulnerable gMG populations.",[28],"2025-09-19",{"date":291,"type":33},"2025-09-24",{"date":289,"type":33},{"date":294,"type":22},"2027-10-01",{"name":296,"class":206},"Centre Hospitalier Universitaire de Nice",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":207},"100551101","markers-of-favorable-response-to-complement-inhibitors-therapy-100551101","NCT06455709","Markers of Favorable Response to Complement Inhibitors Therapy","Identification of Clinical, Biological, Cellular and Genetic Markers of Favorable Response Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis","OPTIMISE","Inclusion Criteria:\n\n* Age ≥18 years;\n* Diagnosis of generalized anti-AChR positive Myasthenia Gravis;\n* Need for therapy with complement inhibitor drugs according to the therapeutic indications approved by AIFA (16);\n* Ability to perform follow-up at the reference center;\n* Signed informed consent to the study.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years;\n* Poor compliance with drug therapy;\n* Concomitant autoimmune diseases;\n* Insufficient availability of clinical information;\n* Ongoing neoplasia or infection at the time of biological sample collection;\n* Refusal to sign the informed consent to the study",{"count":51,"type":22},"Myasthenia gravis is an autoimmune neurological disease caused by autoantibodies primarily directed against components of the postsynaptic membrane of the neuromuscular junction. Approximately 85% of patients have antibodies directed against the acetylcholine receptor (anti-AChR).\n\nAnti-AChR antibodies act through three distinct mechanisms:\n\n1. Activation of the classical complement pathway: Formation of membrane-attack complexes (MACs) results in the destruction of the postsynaptic membrane.\n2. Mechanical blockade: Anti-AChR antibodies block the acetylcholine binding site on its receptor.\n3. Internalization and lysosomal degradation: Bivalent IgG causes cross-linking of adjacent receptors leading to internalization and degradation of AChRs (antigenic modulation).\n\nPatient mortality has significantly reduced due to effective treatments preventing severe exacerbations of myasthenic symptoms.\n\nIn the past five years, the FDA and EMA have approved complement inhibitors for the treatment of generalized myasthenia gravis with anti-AChR antibody positivity. Eculizumab, a humanized monoclonal antibody, binds to the complement fragment C5, inhibiting its cleavage into C5a and C5b, and preventing the formation of the terminal complement complex C5b-9 (MAC).\n\nCurrently, Eculizumab is approved in Italy for generalized myasthenia gravis associated with anti-acetylcholine receptor antibody positivity.\n\nThis class of drugs is generally more effective than conventional immunosuppressive therapies, though it comes with higher costs.\n\nThere is heterogeneity among patients in their response to complement inhibitor therapies. Currently, there is no specific evidence indicating which patients may benefit most from this class of treatments. Personalized therapy, considering the predominant pathogenic mechanisms of anti-AChR in individual patients, seems necessary. Interindividual heterogeneity in the autoantibody repertoire could underlie different responses to complement inhibitor therapies. For example, inhibition of the complement cascade in patients whose autoantibodies also block receptors might result in an unsatisfactory treatment response. Moreover, C5 gene polymorphisms could explain a lack of response to these new drugs. Investigating the immune, genetic, and cellular profile of myasthenic patients eligible for these new pharmacological therapies could be useful for identifying predictive markers of response and personalizing therapeutic choices.",[28],"2025-07-30",{"date":310,"type":33},"2025-08-01",{"date":312,"type":33},"2024-06-05",{"date":314,"type":22},"2026-06-01",{"name":316,"class":206},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":207},"100506011","phase-3-rituximab-efficacy-in-myasthenia-gravis-refine-100506011","NCT05868837","Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)","Single-cell Deep Phenotyping of B Lymphocytes to Personalize Immunotherapy in Patients With Myasthenia Gravis: Clinical Trial to Evaluate the Efficacy and Safety of Rituximab in Generalized AChR-antibody Positive Myasthenia Gravis","REFINE","Inclusion Criteria:\n\na. Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening (one retest allowed), and\n\nAt least one of the following:\n\ni)-History of abnormal neuromuscular transmission test results demonstrated by single- fiber electromyography or repetitive nerve stimulation; or ii)-History of positive anticholinesterase test (eg, edrophonium chloride test); or iii)-Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or iv)-Clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition. c. MGFA Clinical Classification Class II, III, or IV at the time of screening and randomization.\n\nd. MG-ADL score of 5 or greater at screening and at randomization with \\> 50% of this score attributed to non-ocular items. e. QMG score of 11 or greater at screening and at randomization. f. Willing and able to comply with the protocol, complete study assessments, and return for follow- up visits.\n\ng. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception method (Table 1) from the time of screening and for 12 months after the final dose of IP. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. h. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n\ni. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP. Because male condom is not a highly effective contraception method, it is strongly recommended that female partners of a male study subject also use a highly effective method of contraception throughout this period.\n\nExclusion Criteria:\n\n1. Any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of patient safety or study results.\n2. Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus 6 months following last dose of IP.\n3. History of drug or alcohol abuse within \\\u003C 1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.\n4. Site staff and their family members.\n5. Currently committed to an institution by way of official or judicial order.\n6. Subjects diagnosed with congenital myasthenic syndromes.\n7. Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.\n8. Thymectomy within ≤ 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.\n\n10\\. Receipt of the following medications or treatments at any time prior to randomization:\n\n1. Alemtuzumab (Lemtrada®, Campath®)\n2. Total lymphoid irradiation\n3. Bone marrow transplant\n4. T-cell vaccination therapy\n5. Natalizumab (Tysabri®) 10. Receipt of ANY immunosuppressive treatment (excluding corticosteroids) at ANY time prior to randomization (such as Azathioprine, Mycophenolate mofetil or Mycophenolic acid, Cyclosporine (except eye drop), Tacrolimus (except topical), Methotrexate, Cyclophosphamide, Tocilizumab (Actemra®), Belimumab (Benlysta®), Eculizumab (Soliris®), rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent) 11. Receipt within the 4 weeks prior to Day 1:\n\na. Intravenous immunoglobulin (IVIg) b. Plasma exchange (PLEX) treatment 12. Current use of:\n\n1. Prednisone \\\u003C 20 mg\u002Fday or \\\u003C 40 mg over a 2-day period (or equivalent dose of other corticosteroids)\n2. Pyridostigmine \\> 480 mg\u002Fday or unstable dose in the 2 weeks prior to Day 1 13. Concurrent\u002Fprevious enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day 1.\n\n   14\\. Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable. 15. History of severe allergic or anaphylactic reactions to biologic agents or known allergy to any component of the IP formulation. 16. History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics).\n\n   17\\. Within 2 weeks prior to the screening visit: clinically significant active infection requiring antimicrobial medication but allowing chronic nail infections. 18. Unresected thymoma (Note: subjects with a benign thymoma resected \\> 1 year prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination. Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care). 19. History of cancer, except for the following:\n\na. In situ carcinoma of the cervix treated with apparent success with curative therapy for \\> 12 months prior to screening b. Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for \\> 12 months prior to screening c. Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent \\> 3 years prior to screening and without known recurrence or current treatment d. Malignant thymoma (i.e. Masaoka stage ≥ IIa) resected \\> 5 years prior to screening with no evidence of active disease and no therapy received over the previous 5 years. Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care 21. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening.\n\n22\\. Any of the following laboratory abnormalities at screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period):\n\na. Elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)). b. Total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome) c. Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m2 d. CD19+ B-cell count \\\u003C 40 cells\u002FμL e. Absolute neutrophil count (ANC) \\\u003C 1.2 × 103 cells\u002Fμl f. Platelet count \\\u003C 75,000\u002FμL (or \\\u003C 75 × 109\u002FL) g. Hemoglobin \\\u003C 8.0 g\u002FdL h. Total immunoglobulin \\\u003C 600 mg\u002FdL 23. Positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2) a positive hepatitis B core antibody (anti-HBc) PLUS negative hepatitis B surface antibody (anti-HBs). Note: Subjects with a positive anti-HBs only, or a positive anti-HBc plus positive anti-HBs and negative HBsAg, are eligible to enroll. 24. Positive test for hepatitis C virus antibody. 25. Positive HIV test. 26. Blood transfusion within 4 weeks prior to screening or during the screening period.\n\n27\\. Inability to read. 28. History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for tuberculosis was completed per local guidelines. Subjects with latent TB or a positive QuantiFERON®-TB Gold test who are actively on anti-TB treatment can enroll if they have completed at least 1 month of anti-TB treatment and intend to complete the full course of anti-TB treatment. Subjects with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Gold is negative or a tuberculin skin test is negative.",{"count":326,"type":22},40,[80],"The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will:\n\n* Allow faster and greater corticosteroid tapering\n* Reduce the frequency of exacerbations\n* Improve quality of life\n* Offer an acceptable safety and tolerability profile.",[28],{"date":310,"type":33},{"date":332,"type":33},"2022-02-28",{"date":334,"type":22},"2025-07-31",{"name":316,"class":206},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100444432","phase-2-efficacy-and-safety-of-tocilizumab-in-the-treatment-of-generalized-myasthenia-gravis-100444432","NCT05067348","Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis","A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis","tMG","Inclusion Criteria:\n\n1. Diagnosis of MG with anti-AChRantibody.\n2. MGFA Clinical Classification Class II, III, or IV.\n3. MG-ADL score of 5 or greater at screening and at randomization with \\> 50% of this score attributed to non-ocular items.\n4. QMG score of 11 or greater.\n5. Subjects must be on:\n\n   1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;\n   2. Corticosteroids, with no dose increase within 4 weeks prior to randomization; or\u002Fand c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.\n\nExclusion Criteria:\n\n1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;\n2. Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;\n3. Human immunodeficiency virus (HIV) infection;\n4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and\u002For radiotherapy at any time;\n5. Received rituximab treatment in the past 6 months before randomization;\n6. Received tocilizumab or eculizumab treatment within 3 months before randomization;\n7. Received IVIG or plasma exchange within 4 weeks before randomization;\n8. Unresected thymoma.\n9. History of other tumor diseases.",{"count":345,"type":22},64,[25],"Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.",[28],[57,350],"Tocilizumab","2025-04-28",{"date":353,"type":33},"2025-05-01",{"date":355,"type":33},"2022-07-21",{"date":357,"type":22},"2026-03-30",{"name":359,"class":206},"Tang-Du Hospital",6,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":207},"100553372","early-phase-1-universal-car-t-cells-in-patients-with-refractory-autoimmune-diseases-of-the-nervous-system-100553372","NCT06485232","Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.","An Exploratory Study on the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases of the Nervous System","Inclusion Criteria:\n\n* Aged 18-75 years (for MS patients, 18-55 years); both genders eligible.\n* Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS).\n* Anticipated survival of ≥ 12 weeks as judged by the researcher.\n* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* History of solid organ transplantation.\n* Malignant tumor within the last two years.\n* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.\n* Primary immunodeficiency (congenital or acquired).\n* Severe cardiac disease.\n* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.\n* Allergic constitution or a history of severe allergies.\n* Pregnant or breastfeeding women.","75 Years",{"count":238,"type":22},[371],"EARLY_PHASE1","This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.",[374,28,155,375],"Neuromyelitis Optica Spectrum Disorders","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",[377,374,265,155,375],"universal CAR-T","2024-12-30",{"date":380,"type":33},"2025-01-01",{"date":382,"type":22},"2025-02-28",{"date":384,"type":22},"2027-12-31",{"name":386,"class":206},"Xuanwu Hospital, Beijing",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":207},"100568732","markers-of-favorable-response-to-fcrn-inhibitorsinform-100568732","NCT06685055","Markers of Favorable Response to FcRn Inhibitors(INFORM)","Identification of Clinical, Biological, Cellular and Genetic Markers of Favorable Response to Therapy With Neonatal Fc Receptor Inhibitors for Immunoglobulins (FcRn) in Patients With Generalized Myasthenia Gravis (INFORM)","INFORM","Inclusion Criteria:\n\n\\- Age ≥18 years.\n\n* Diagnosis of generalized anti-AChR positive Myasthenia Gravis.\n* Need for therapy with neonatal Fc receptor inhibitors for immunoglobulins (FcRn) as per AIFA-approved therapeutic indications (14).\n* Ability to follow up at the reference center.\n* Signed informed consent for the study.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n\n  * Poor compliance with drug therapy.\n  * Concurrent autoimmune diseases.\n  * Insufficient availability of clinical information.\n  * Ongoing neoplasm or infection at the time of biological sample collection.\n  * Refusal to sign the informed consent for the study.",{"count":51,"type":22},"Myasthenia gravis is an autoimmune neurological disease caused by autoantibodies primarily directed against components of the postsynaptic membrane of the neuromuscular junction. Approximately 85% of patients have antibodies directed against the acetylcholine receptor (anti-AChR).\n\nAnti-AChR antibodies act through three distinct mechanisms:\n\n1. Activation of the classical complement pathway: Formation of membrane-attack complexes (MACs) results in the destruction of the postsynaptic membrane.\n2. Mechanical blockade: Anti-AChR antibodies block the acetylcholine binding site on its receptor.\n3. Internalization and lysosomal degradation: Bivalent IgG causes cross-linking of adjacent receptors leading to internalization and degradation of AChRs (antigenic modulation).\n\nPatient mortality has significantly reduced due to effective treatments preventing severe exacerbations of myasthenic symptoms.\n\nIn the past five years, the FDA and EMA have approved complement inhibitors and FcRn inhibitors for treating generalized myasthenia gravis with anti-AChR antibodies. Many other therapies are currently in phase 3 clinical trials or under regulatory review. However, there is no specific evidence to support which patients benefit most from one treatment class over another.\n\nGiven their relative efficacy compared to conventional therapies and high costs, their future role in the therapeutic arsenal is unclear. A personalized approach considering the different pathogenic mechanisms of anti-AChR and single gene polymorphisms involved in treatment response is essential for effective therapeutic choice. In July 2023, AIFA approved the reimbursement of Efgartigimod in Italy for treating adult patients with generalized myasthenia gravis with anti-AChR antibodies, in addition to standard therapy.\n\nFcRn inhibitors (including Efgartigimod) prevent the interaction of IgG with the neonatal Fc receptor for immunoglobulin fragments, reducing IgG recycling and promoting the degradation of IgG and pathogenic antibodies without affecting albumin levels.\n\nThere is heterogeneity among patients in their response to FcRn inhibitors therapies. Currently, there is no specific evidence indicating which patients may benefit most from this class of treatments. Interindividual heterogeneity in the autoantibody repertoire, predominance of different pathogenic mechanisms, and single gene polymorphisms affecting treatment response. Investigating the immune profile and specific gene polymorphisms in myasthenic patients needing these innovative therapies could identify predictive biomarkers and personalize therapeutic choices.",[241],"2024-11-11",{"date":400,"type":33},"2024-11-12",{"date":402,"type":33},"2024-07-09",{"date":404,"type":22},"2026-07-09",{"name":316,"class":206},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":415,"studyType":52,"phases":4,"briefSummary":416,"conditions":417,"keywords":429,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":207},"100563559","myasthenia-gravis-foundation-of-america-global-mg-patient-registry-100563559","NCT06617741","Myasthenia Gravis Foundation of America Global MG Patient Registry","MGFAPR","Inclusion Criteria:\n\n* age over 18\n* positive MG diagnosis\n\nExclusion Criteria:\n\n* age under 18\n* misdiagnosed with MG",{"count":414,"type":22},3800,"15 Years","The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:\n\n* How and when are people with MG diagnosed?\n* What are the most common symptoms associated with MG?\n* What treatments are being used to treat MG?\n* What are the impacts of MG on activities of daily living, employment and quality of life?\n* What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.",[418,419,420,421,422,423,424,425,28,426,427,265,428],"Myasthaenia Gravis","Myasthenia","Myasthenia Gravis Associated with Thymoma","Myasthenia Gravis Crisis","Myasthenia Gravis Exacerbations","Myasthenia Gravis Generalised","Myasthenia Gravis with Exacerbation (Disorder)","Myasthenia Gravis, Adult Form","Myasthenia Gravis, Ocular","Myasthenia Gravis, Thymectomy","Myasthenia Gravis, MuSK",[430,431,432,433,243],"myasthenia","patient registry","MGFA","Myasthenia Gravis Foundation of America","2024-09-26",{"date":436,"type":33},"2024-09-27",{"date":438,"type":33},"2013-10-12",{"date":440,"type":22},"2029-09-19",{"name":433,"class":206},{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":17,"minAge":448,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":450,"conditions":451,"keywords":459,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":207},"100455749","predictors-and-prognostic-factors-of-myasthenia-gravis-outcome-100455749","NCT05214612","Predictors and Prognostic Factors of Myasthenia Gravis Outcome","Inclusion Criteria:\n\n1. Age from 16 years and older.\n2. Gender: both sexes are included.\n3. Clinical Diagnosis of MG with supporting evidence as:\n\n   1. unequivocal clinical response to pyridostigmine\n   2. decrement \\>10% in repetitive nerve stimulations study (RNS).\n4. Willingness to sample collection, imaging study and other disease-related examinations and assessments.\n\nExclusion Criteria:\n\n1. Age younger than 16 years.\n2. History of chronic psychiatric or neurological disorder other than MG that can produce weakness or fatigue.\n3. Severe systemic illness affecting life-expectancy.","16 Years",{"count":21,"type":22},"This study aims to characterize the clinical features, frequency of different subgroups of MG, and identify predictors of treatment responsiveness among different subgroups of MG. The predictors are including primary outcome (percentage of changes in MG scales at baseline at time of enrollment and after 3 months) and secondary outcome (treatment-related adverse events). Also it aims to determine the frequency of patients with refractory MG.\n\nThis information will be used to understand the trends and mechanisms of disease relapse, and optimal management strategies.",[265,452,453,454,455,456,28,426,421,457,425,458],"Autoimmune Diseases of the Nervous System","Neuromuscular Junction Diseases","Thymoma","Thymus Hyperplasia","Nervous System Diseases","Myasthenia Gravis With Exacerbation (Disorder)","Myasthenia Gravis, Juvenile Form",[460,461,265,462],"Predictors","Prognostic factors","Outcome","2024-07-30",{"date":465,"type":33},"2024-07-31",{"date":467,"type":33},"2022-01-01",{"date":469,"type":22},"2025-03-31",{"name":471,"class":206},"Assiut University"]