[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myasthenia-gravis-crisis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myasthenia-gravis-crisis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,68,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100582232","phase-4-treatment-of-myasthenia-gravis-exacerbation-or-crisis-with-efgartigimod-100582232",false,"NCT06860633","Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod","Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study","Inclusion Criteria:\n\n* Adults ≥ age 18 years with known generalized MG as identified by characteristic signs of generalized MG on clinical assessment and positive serology for AchR antibodies as well as one of the following:\n\n  1. Documented positive response to cholinesterase inhibitors such as pyridostigmine or edrophonium\n  2. Abnormal decrement on slow repetitive nerve stimulation testing\n  3. Abnormal single fiber EMG\n* Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:\n\n  1. Quantitative Myasthenia Gravis (QMG) scale ≥ 11\n  2. MG-ADL score ≥ 6\n  3. Worsening weakness that is unlikely to be ameliorated by adjustment of current medications including impaired respiratory status, dysarthria, dysphagia, difficulty chewing, limb weakness, diplopia, ptosis.\n* Ability to sign consent and be enrolled within 24 hours of hospital admission. For participants transferred to University of Colorado Hospital, the time of admission\u002Fpresentation to the outside hospital is counted towards this 24-hour cap.\n\nExclusion Criteria:\n\n* MG worsening thought to be related to active infection or due to medications (e.g. fluoroquinolone or aminoglycoside antibiotics, magnesium, chloroquine derivatives)\n* Intubation prior to ability to sign informed consent or intubation within 24 hours of hospitalization\n* Use of IVIG within 2 weeks, or having undergone plasma exchange or received efgartigimod in the 4 weeks prior to admission\n* Current ongoing use of ravulizumab or eculizumab (monoclonal antibody C5-complement inhibitors).\n* Other medical conditions that, in the opinion of the investigator and treating clinicians, might interfere with the validity of assessment measures used in the study (e.g. steroid myopathy, CNS pathology, severe arthritis, fractures, etc.). This criterion is a standard exclusion in MG trials and relates solely to other conditions that reduce muscle power or range of motion and would thus worsen scores on assessment measures like the QMG due to non-MG conditions.\n* Known history of coagulopathy, blood clotting, recent severe bleeding (e.g. GI bleed).\n* Pregnancy or breastfeeding. Pregnancy must be excluded for all potential participants who are able to become pregnant prior to initiation of treatment.\n* IgG levels \\\u003C 600mg\u002FdL\n* Evidence of active or chronic Hepatitis B infection, untreated Hepatitis C infection, HIV with low CD4 (\\\u003C200) count.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as \"exacerbation\"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are:\n\n* Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization?\n* Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies?\n\nParticipants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.",[26,27,28],"Myasthenia Gravis Crisis","Myasthenia Gravis Exacerbations","AChR Myasthenia Gravis",[30,31],"myasthenia exacerbation","efgartigimod","RECRUITING","2025-07-10",{"date":35,"type":36},"2025-07-11","ACTUAL",{"date":38,"type":36},"2025-03-06",{"date":40,"type":20},"2026-12-31",{"name":42,"class":43},"University of Colorado, Denver","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100568977","phase-4-intravenous-human-igg1-fc-fragment-efgartigimod-in-myasthenic-crisis-100568977","NCT06688253","Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis","Inclusion Criteria:\n\n* -Age \\> 18\n* MG diagnosis\n* A confirmed diagnosis of Myasthenia Gravis (MG) with generalized muscle weakness, classified as MGFA class II, III, IVa, or IVb and V.\n* Positive AchR or MuSK antibodies (max three patients of the total cohort) this will be tested in our center for all patients.\n* Myasthenic crisis: Worsening of \\> 3 or an increase \\>1 MG-ADL points of a sub score of any individual MG-ADL item other than double vision or eyelid droop and its clinically significant by the investigator. Alternatively, weakness related to MG that is severe enough to necessitate intubation or delay Ex-tubation following surgery.\n* Willingness to provide informed consent.\n\nExclusion Criteria:-Contraindications to Efgartigimod.\n\n* Other significant medical conditions that may interfere with study participation.\n* Prior exposure to Efgartigimod.\n* Male patients who do not intend to use effective contraception during trail or within last dosing\n* Pateints with worsening muscle weekness due to concurrent infection or medications known to exacerbate MG.\n* Patients with known or active seropositive HBV,HCV, HIV.\n* Patients with documented lack of clinical response to Flax.\n* Use of any investigational drug within 3 month or 5 helf -lives prior to screening.\n* Avidance of significant disease ,recent major surgery or renal\u002F hepatic function who can put patient at undue risk.\n* Previous participation in clinic trail involving ARGX-113\n* Vaccination recived whitin 4 weeks prior screening using live or attenuated vaccinations.\n* Patient Calssified MGFA Class 1\n\n  1. Pregnant and lactating women","99 Years",{"count":53,"type":20},16,[23],"Efgartigimod in Myasthenic Crisis Background Myasthenia gravis (MG) is a prevalent autoimmune disorder affecting neuromuscular junctions, characterized by weakness in skeletal muscles. It is associated with the production of autoantibodies, primarily targeting acetylcholine receptors (AchR), and is often complicated by myasthenic crisis, which can lead to severe respiratory failure. Current treatments primarily involve non-specific immunosuppression, which may not provide rapid relief.\n\nAim This study investigates the therapeutic impact of efgartigimod, an FcRn-targeting Fc fragment, on patients experiencing a myasthenic crisis. We hypothesize that efgartigimod is non-inferior to conventional treatments like intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) in terms of clinical efficacy and safety.\n\nStudy Rationale Efgartigimod aims to reduce pathogenic IgG autoantibodies implicated in MG by accelerating their degradation. This targeted approach could provide faster symptom relief during acute exacerbations compared to existing therapies.\n\nObjectives Primary Objective: To assess the non-inferiority of efgartigimod compared to PLEX and IVIG based on MG-ADL improvements.\n\nSecondary Objectives: Evaluate safety, tolerability, length of hospital stay, respiratory parameters, need for additional therapies, and one-year outcomes.\n\nPrimary Endpoint MG-ADL Improvement: Defined as a ≥3-point improvement post-treatment. The comparison will be made using one-month post-treatment assessments, with follow-ups every three months.\n\nSecondary Endpoints Safety and tolerability Length of hospital stay Changes in respiratory function Need for rescue therapy in case of clinical deterioration Sample Size The study will recruit 32 patients (16 historical group and 16 interventional group), calculated to detect significant differences in MG-ADL improvements with a significance level of 0.05 and power of 0.80.\n\nPatient Recruitment Patients with a confirmed diagnosis of MG who present to the neurology department will be recruited and randomly assigned to either the efgartigimod treatment group or the historical control group receiving standard care (IVIG\u002FPLEX).\n\nInclusion Criteria Adults \\> 18 years Confirmed MG diagnosis with generalized weakness (MGFA class II-V) Positive AchR or MuSK antibodies Evidence of myasthenic crisis Informed consent Exclusion Criteria Contraindications to efgartigimod Significant comorbidities affecting study participation Prior exposure to efgartigimod Ongoing infections or conditions exacerbating MG symptoms Recent major surgery or significant renal\u002Fhepatic dysfunction Planned Protocol Administer efgartigimod intravenously at 10 mg\u002Fkg weekly for four weeks. Total trial duration: 12 months for enrollment and treatment, followed by a 14-month follow-up.",[26],[26],"NOT_YET_RECRUITING","2024-11-13",{"date":61,"type":36},"2024-11-14",{"date":63,"type":20},"2024-11-15",{"date":65,"type":20},"2025-03-30",{"name":67,"class":43},"Rambam Health Care Campus",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":44},"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":76,"type":20},3800,"15 Years","OBSERVATIONAL","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.",[81,82,83,26,27,84,85,86,87,88,89,90,91],"Myasthaenia Gravis","Myasthenia","Myasthenia Gravis Associated with Thymoma","Myasthenia Gravis Generalised","Myasthenia Gravis with Exacerbation (Disorder)","Myasthenia Gravis, Adult Form","Myasthenia Gravis, Generalized","Myasthenia Gravis, Ocular","Myasthenia Gravis, Thymectomy","Myasthenia Gravis","Myasthenia Gravis, MuSK",[93,94,95,96,97],"myasthenia","patient registry","MGFA","Myasthenia Gravis Foundation of America","myasthenia gravis","2024-09-26",{"date":100,"type":36},"2024-09-27",{"date":102,"type":36},"2013-10-12",{"date":104,"type":20},"2029-09-19",{"name":96,"class":43},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":115,"conditions":116,"keywords":124,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":44},"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":114,"type":20},30,"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.",[90,117,118,119,120,121,87,88,26,122,86,123],"Autoimmune Diseases of the Nervous System","Neuromuscular Junction Diseases","Thymoma","Thymus Hyperplasia","Nervous System Diseases","Myasthenia Gravis With Exacerbation (Disorder)","Myasthenia Gravis, Juvenile Form",[125,126,90,127],"Predictors","Prognostic factors","Outcome","2024-07-30",{"date":130,"type":36},"2024-07-31",{"date":132,"type":36},"2022-01-01",{"date":134,"type":20},"2025-03-31",{"name":136,"class":43},"Assiut University"]