[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360581":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":75,"collaborators":24,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":24,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":92,"conditions":93,"keywords":24,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"The serum concentration of soluble TWEAK","We will then compare the soluble TWEAK concentrations observed in patients with anti-TWEAK antibodies and in patients without anti-TWEAK antibodies. We will study the correlation between the concentrations of soluble TWEAK and those of soluble TNF.","1 year",[14,17,20,22],{"measure":15,"description":16,"timeFrame":12},"The titers of anti-TWEAK antibodies","Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample",{"measure":18,"description":19,"timeFrame":12},"Functional properties of anti-TWEAK antibodies","Positive or negative test Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample",{"measure":21,"description":16,"timeFrame":12},"Soluble TWEAK concentrations",{"measure":23,"description":16,"timeFrame":12},"Serum concentrations of soluble TNF",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":6,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","This is a single-center interventional study with minimal risks and constraints on a cohort of MS patients. Patients with clinically isolated syndrome suggestive of MS will be included prospectively and consecutively.",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","Multiple sclerosis (MS) is the most common chronic autoimmune demyelinating and neurodegenerative disease of the central nervous system (CNS) of disabling neurological diseases in young adults in France. Patients with MS can present a wide range of symptoms spread over time and space such as motor, sensory, visual or vesico-sphincter deficits. One of the current challenges in treating patients with symptoms suggestive of MS is to assess the risk of an inflammatory flare in order to avoid or limit the installation of an irreversible neurological handicap. At present, the inflammatory activity of the disease is evaluable only by cerebral imaging (MRI). However, these examinations can not be carried out as often as necessary because of their accessibility, cost, duration and the potential deleterious effects of gadolinium accumulation. This is why a blood biomarker able to report early on the inflammatory activity of the disease would be of great help during the monitoring and treatment of patients. TWEAK (TNF-related weak inducer of apoptosis or TNFSF12) is a pro-inflammatory cytokine member of the TNF family. This cytokine is overexpressed in tissues with chronic inflammatory diseases such as MS. It is produced by monocytes \u002F macrophages and microglial cells and can exist in soluble or membrane form the investigators of the clinical department were the first to describe the pro-inflammatory role of TWEAK in MS. Indeed, the investigators have demonstrated in an animal model of MS that the inhibition of TWEAK makes it possible to reduce the severity of the disease. Their recent work (manuscript submitted for publication) has also shown results from a series of 28 patients with MS suggesting that the serum TWEAK assay may be an early marker of thrust occurrence. The investigators propose to study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak. The investigators will perform a prospective study in which 50 patients with MS in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).",[33],{"label":34,"type":6,"description":35,"interventionNames":36},"serum concentration changes in cytokine TWEAK","We will perform a prospective study in which 50 patients with multiple sclerosis in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).",[37],"Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":24},"DIAGNOSTIC_TEST","Determination of the circulating serum concentration of cytoquine TWEAK","Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team.",[34],[45],{"name":46,"affiliation":47,"role":48},"Jean-Olivier ARNAUD","Assistance Publique des Hôpitaux de Marseille","STUDY_DIRECTOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":24,"email":54},"Sophie DESPLAT-JEGO","CONTACT","+ 33 4 91 38 39 07","sophie.jego-desplat@ap-hm.fr",[56],{"facility":57,"status":58,"city":59,"state":24,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Assistance Publique Hopitaux de Marseille","RECRUITING","Marseille","13354","France","FR",{"type":64,"coordinates":65},"Point",[66,67],5.38107,43.29695,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":73,"email":74},"Sophie DESPLAT-JEGO, IP","04 91 38 39 07","+33","promotion.interne@ap-hm.fr",{"type":76,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100360581","multiple-sclerosis-100360581",false,"NCT03974997","TWEAK, a New Biomarker for Predicting Inflammatory Relapses in Multiple Sclerosis","TNF-related Weak Inducer of Apoptosis (TWEAK), a New Biomarker Predicting Inflammatory Thrust in Multiple Sclerosis","TWEAK","Inclusion Criteria:\n\n* a first episode of inflammation and demyelination of the central nervous system affecting the optic nerve, the spinal cord, one cerebral hemisphere, or the brainstem; or confirmed multiple sclerosis\n* no differential diagnosis at enrollment based on clinical examination and laboratory tests\n* compliance with the revised 2017 Mac Donald diagnostic criteria\n\nExclusion Criteria:\n\n* age \\\u003C18 years old\n* person in an emergency situation\n* adult who is subject to a legal protection measure (an adult under guardianship, conservatorship, or judicial protection), or who is unable to give consent\n* not Enrolled in a Social Security Program\n* pregnant or breastfeeding woman","ALL","18 Years",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[26],"A significant variation in the serum concentration of the circulating cytokine TWEAK is associated with the onset of an inflammatory attack of MS. Study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak.",[94],"Multiple Sclerosis","2026-09-18",{"date":97,"type":98},"2026-09-23","ACTUAL",{"date":100,"type":98},"2023-06-16",{"date":102,"type":89},"2027-06-16",{"name":5,"class":6},1]