[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580905":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":23,"locations":28,"responsibleParty":42,"collaborators":45,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Teriflunomide Cohort",null,"Participants with relapsing multiple sclerosis who initiate teriflunomide as part of routine clinical care. Individuals in this cohort undergo standardized assessments of physical and cognitive fatigability, functional performance, clinical status, patient-reported outcomes, and routinely obtained MRI findings at baseline and at 3, 6, 9, and 12 months. No experimental treatment is administered, and all therapeutic decisions remain under the responsibility of the treating physician.",{"label":13,"type":10,"description":14,"interventionNames":10},"Dimethyl Fumarate Cohort","Participants with relapsing multiple sclerosis who initiate dimethyl fumarate as part of routine clinical care. Individuals in this cohort complete standardized evaluations of physical and cognitive fatigability, functional performance, clinical status, patient-reported outcomes, and routinely acquired MRI measures at baseline and at 3, 6, 9, and 12 months. No experimental intervention is provided, and all treatment decisions are made independently by the treating physician.",[16,20],{"name":17,"affiliation":18,"role":19},"Husnu Efendi, Prof.","Kocaeli University","STUDY_CHAIR",{"name":21,"affiliation":5,"role":22},"Mehmet Fatih Yetkin Assoc. Prof. MD, Assoc. Prof.","PRINCIPAL_INVESTIGATOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","905428203060","drfatihmehmet@gmail.com",[29],{"facility":30,"status":10,"city":31,"state":10,"zip":10,"country":32,"countryCode":10,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Erciyes University","Kayseri","Turkey (Türkiye)",{"type":34,"coordinates":35},"Point",[36,37],35.48528,38.73222,{"lat":37,"lon":36},[40],{"name":41,"role":25,"phone":26,"phoneExt":10,"email":27},"Mehmet Fatih Yetkin Assoc. Prof. MD, Assoc. Prof. MD",{"type":22,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mehmet Fatih Yetkin","Principal Investigator, Head of Multiple Sclerosis Unit of Erciyes University",[46,48,49],{"name":47,"class":6},"Sakarya University",{"name":18,"class":6},{"name":50,"class":51},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV","100580905","real-world-experience-of-oral-agents-on-fatigability-in-multiple-sclerosis-100580905",false,"NCT06843382","Real-world Experience of Oral Agents On Fatigability in Multiple Sclerosis","Real-World Comparative Effects of Teriflunomide and Dimethyl Fumarate on Physical and Cognitive Fatigability in Multiple Sclerosis: The ROOF-MS Multicenter Prospective Cohort Study","ROOF-MS","Inclusion Criteria:\n\n* Relapsing Multiple Sclerosis (RRMS or active SPMS) diagnosis, confirmed according to the 2017 revised McDonald criteria.\n* 18 years or older at the time of enrollment.\n* Newly initiated teriflunomide treatment as part of routine clinical care.\n* Ambulatory status (EDSS ≤ 7.0), capable of completing study assessments.\n* Ability and willingness to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Diagnosis of Primary Progressive Multiple Sclerosis (PPMS).\n* Severe comorbidities affecting mobility or cognitive function (e.g., advanced cardiovascular, pulmonary, or neuromuscular disease).\n* Neurological or psychiatric conditions that prevent cognitive testing (e.g., advanced cognitive impairment, untreated severe depression).\n* Severe upper extremity motor dysfunction, limiting 9-Hole Peg Test (9-HPT) or Symbol Digit Modalities Test (SDMT) completion.\n* Pregnancy or breastfeeding at the time of enrollment.\n* Inability to comply with study visits at baseline, 3 months, 6 months, and 12 months.","ALL","18 Years","75 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL","This multicenter, prospective, real-world study evaluates how two commonly used oral disease-modifying therapies-teriflunomide and dimethyl fumarate-affect physical and cognitive fatigability in adults with multiple sclerosis (MS). Fatigability refers to an objective decline in physical or cognitive performance during sustained activity and represents a major barrier to daily functioning for many individuals with MS.\n\nParticipants starting either teriflunomide or dimethyl fumarate as part of routine clinical care will be followed for 12 months at regular visits (baseline, 3, 6, 9, and 12 months). At each visit, standardized assessments will measure walking endurance, gait performance, hand function, and information-processing speed. Patient-reported outcomes about fatigue, mood, quality of life, and daily functioning will also be collected. Brain MRI scans performed as part of usual care will be reviewed to document disease activity.\n\nThe goal of the ROOF-MS study is to understand whether these two therapies differ in their impact on physical and cognitive fatigability, functional outcomes, symptom burden, and real-world treatment adherence. Because this is an observational study, no experimental treatments are given, and all clinical decisions remain the responsibility of the treating physicians.\n\nBy examining fatigability in everyday clinical settings, this study aims to generate evidence that can help patients, families, and health care providers make more informed treatment decisions.",[69],"Multiple Sclerosis",[69,71,72,73],"Teriflunomide","Fatigability","Real-world study","NOT_YET_RECRUITING","2025-11-18",{"date":77,"type":78},"2025-11-21","ACTUAL",{"date":80,"type":65},"2025-11-20",{"date":82,"type":65},"2027-06-15",{"name":5,"class":6},1]