[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580905":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":52,"studyPopulation":53,"armGroups":54,"interventions":49,"overallOfficials":61,"centralContacts":69,"locations":74,"responsibleParty":88,"collaborators":91,"id":98,"slug":49,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":49,"studyType":111,"phases":49,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":119,"whyStopped":49,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"TC Erciyes University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"Walking Fatigability Index","Walking fatigability will be quantified using the Distance Walk Index (DWI), calculated with the following formula:\n\nDWI=(Distance at minute 6-Distance at minute 1Distance at minute 1)×100 DWI=(Distance at minute 1Distance at minute 6-Distance at minute 1 )×100\n\nA DWI decline of \\>10% will be classified as abnormal, based on prior relapsing-remitting MS studies.\n\nUnit of Measurement: Percentage (%) Time Frame: Baseline, 3 months, 6 months, and 12 months Higher Values Indicate: Better walking endurance (lower fatigability)","Assessments will be conducted at baseline, at three months, at six months, and at twelve months following treatment initiation.",{"measure":14,"description":15,"timeFrame":16},"Cognitive Fatigability Index","Cognitive fatigability will be quantified using the Cognitive Fatigability Index (CFI), calculated with the following formula:\n\nCFI=(SDMT3-SDMT1SDMT1)×100 CFI=(SDMT1SDMT3-SDMT1 )×100\n\nA negative CFI value will indicate cognitive fatigability, with a decline greater than 10% classified as abnormal.\n\nUnit of Measurement: Percentage (%) Higher Values Indicate: Better cognitive endurance (lower fatigability)","Baseline, 3 months, 6 months, and 12 months",[18,21,25,28,31,34,37,40],{"measure":19,"description":20,"timeFrame":16},"Walking Performance","Walking performance will be assessed using the 6-Minute Walk Test (6MWT). The total distance walked (meters) and walking speed (meters per minute, m\u002Fmin) will be recorded.\n\nUnit of Measurement: Meters (m), Meters per minute (m\u002Fmin) Higher Values Indicate: Better walking endurance",{"measure":22,"description":23,"timeFrame":24},"Radiological Outcomes","Radiological outcomes will assess MRI changes at baseline, 6 months, and 12 months to evaluate disease progression and lesion activity in MS.\n\nT2 Lesions: Total number of T2-weighted hyperintense lesions. Gadolinium-Enhancing Lesions: Presence and count of Gd-enhancing lesions. New Lesions: Number of newly developed brain and spinal cord lesions. Upper Cervical Spinal Lesions: Presence of lesions in C1-C4 spinal cord region. Brainstem Lesions: Identification of lesions in the brainstem.\n\nUnit: Lesion count per MRI scan Higher Values Indicate: Increased disease activity","Radiological outcomes will be assessed at three time points: baseline (prior to treatment initiation), 6 months after starting treatment, and 12 months after starting treatment.",{"measure":26,"description":27,"timeFrame":16},"Walking Endurance","Walking endurance will be assessed using the 6-Minute Walk Test (6MWT). Participants will walk at their fastest pace to cover the maximum distance within six minutes, following the standardized protocol by Goldman et al. The total distance walked (meters) will be recorded as the primary measure of endurance.\n\nUnit of Measurement: Meters (m) Higher Values Indicate: Better walking endurance (lower fatigability)",{"measure":29,"description":30,"timeFrame":16},"Processing Speed and Attention","Processing speed and sustained attention will be assessed using the Symbol Digit Modalities Test (SDMT), a validated neurocognitive test. Participants will complete the SDMT in a 90-second timed format following the standardized protocol.\n\nCorrect responses will be recorded at three consecutive 30-second intervals, and the total number of correct responses will be reported.\n\nUnit of Measurement: Number of correct responses Higher Values Indicate: Better cognitive processing speed and sustained attention",{"measure":32,"description":33,"timeFrame":16},"Hand Coordination and Dexterity","Hand coordination and dexterity will be evaluated using the 9-Hole Peg Test (9-HPT) for both hands. The time (in seconds) required to complete the task will be recorded.\n\nUnit of Measurement: Seconds (s) Higher Values Indicate: Worse dexterity",{"measure":35,"description":36,"timeFrame":16},"Fatigue Severity","Fatigue severity will be evaluated using the Fatigue Impact Scale (FIS), a validated patient-reported measure assessing the perceived impact of fatigue on cognitive, physical, and psychosocial functioning. Participants rate the extent to which fatigue has affected daily activities during the previous month. Higher scores indicate greater fatigue-related impact.\n\nTime Frame: Baseline, Month 3, Month 6, Month 9, Month 12 Type of Outcome: Patient-Reported Outcome Measure Method of Aggregation: Mean change from baseline and longitudinal trajectory over 12 months.",{"measure":38,"description":39,"timeFrame":16},"Treatment Satisfaction","Treatment satisfaction will be measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). This instrument assesses satisfaction with medication across different domains (effectiveness, side effects, convenience, and global satisfaction).\n\nUnit of Measurement: TSQM Score (range to be specified) Higher Values Indicate: Greater treatment satisfaction",{"measure":41,"description":42,"timeFrame":16},"Anxiety and Depression","Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales:\n\nHADS-Anxiety (HADS-A): Scores range from 0 to 21, with higher scores indicating greater anxiety.\n\nHADS-Depression (HADS-D): Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.\n\nUnit of Measurement: HADS Score (0-21 per subscale) Higher Values Indicate: Greater anxiety or depression",[44],{"measure":45,"description":46,"timeFrame":47},"Safety outcomes","The safety profile of teriflunomide will be assessed by monitoring the incidence, severity, and type of adverse events (AEs), including laboratory abnormalities, hair thinning or loss, and other treatment-related side effects. Serious adverse events (SAEs) will be categorized according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0), assessing their severity and relationship to treatment.\n\nUnit: Incidence count of AEs\u002FSAEs\n\nHigher Values Indicate: Increased treatment-related adverse events","From enrollment through study completion at 12 months, with assessments at baseline, 3 months, 6 months, and 12 months",{"allocation":49,"interventionModel":49,"interventionModelDescription":49,"primaryPurpose":49,"observationalModel":50,"timePerspective":51,"maskingInfo":49},null,"COHORT","PROSPECTIVE","This investigator-initiated, multicenter, prospective observational cohort study examines longitudinal changes in physical and cognitive fatigability among adults with multiple sclerosis (MS) initiating teriflunomide or dimethyl fumarate as part of routine clinical care. The study integrates standardized fatigability assessments into real-world clinical workflows across participating neurology centers.\n\nFatigability represents an objective performance decline during sustained motor or cognitive activity and provides information that is complementary to subjective fatigue ratings. To quantify physical fatigability, the study applies a structured 6-Minute Walk Test protocol in which distance covered during each minute is recorded. The primary physical fatigability index (DWI6-1) is calculated as the percentage change between the first and sixth minutes, enabling sensitive detection of time-dependent gait deterioration. Cognitive fatigability is quantified via a timed Symbol Digit Modalities Test procedure in which correct responses are recorded at three consecutive 30-second intervals. The Cognitive Fatigability Index (CFI-SDMT) reflects the proportional change between early and late test performance. Both indices allow continuous modeling of longitudinal trajectories and group differences.\n\nAll assessments are performed at baseline (within 30 days of treatment initiation) and at months 3, 6, 9, and 12. Functional performance measures (6MWT total distance, Timed 25-Foot Walk, Nine-Hole Peg Test), clinical evaluations (EDSS), patient-reported outcomes (FIS, TSQM, HADS), and MRI findings obtained during routine care are incorporated to contextualize patterns of fatigability. Test administration is standardized across centers through written manuals and joint training sessions. To minimize diurnal variability, fatigability tests are scheduled at approximately the same time of day for each participant.\n\nBecause the study is non-interventional, treatment decisions-including drug choice, dosing, and management of side effects-are determined solely by treating physicians. Data are recorded in a secure electronic capture platform using coded identifiers, with center-level access restrictions and prospective time-locked entry to maintain data integrity. All analyses follow a predefined statistical plan using mixed-effects modeling with participant- and center-level random effects to account for repeated measures and between-center heterogeneity.\n\nThis study aims to clarify real-world differences in fatigability trajectories between teriflunomide and dimethyl fumarate and to determine how these trajectories relate to functional performance, symptomatic burden, radiological disease activity, and treatment adherence in routine MS care.","The study population will consist of adult patients aged 18 years or older with a confirmed diagnosis of relapsing Multiple Sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS), according to the 2017 revised McDonald criteria. Participants will be selected from routine clinical settings where teriflunomide has been prescribed as part of standard care. Eligible individuals must be ambulatory, with an Expanded Disability Status Scale (EDSS) score of 7.0 or lower, and capable of performing the 6-Minute Walk Test (6MWT). This population will represent a real-world cohort reflective of patients receiving teriflunomide in typical clinical practice.",[55,58],{"label":56,"type":49,"description":57,"interventionNames":49},"Teriflunomide Cohort","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":59,"type":49,"description":60,"interventionNames":49},"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.",[62,66],{"name":63,"affiliation":64,"role":65},"Husnu Efendi, Prof.","Kocaeli University","STUDY_CHAIR",{"name":67,"affiliation":5,"role":68},"Mehmet Fatih Yetkin Assoc. Prof. MD, Assoc. Prof.","PRINCIPAL_INVESTIGATOR",[70],{"name":67,"role":71,"phone":72,"phoneExt":49,"email":73},"CONTACT","905428203060","drfatihmehmet@gmail.com",[75],{"facility":76,"status":49,"city":77,"state":49,"zip":49,"country":78,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Erciyes University","Kayseri","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],35.48528,38.73222,{"lat":83,"lon":82},[86],{"name":87,"role":71,"phone":72,"phoneExt":49,"email":73},"Mehmet Fatih Yetkin Assoc. Prof. MD, Assoc. Prof. MD",{"type":68,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Mehmet Fatih Yetkin","Principal Investigator, Head of Multiple Sclerosis Unit of Erciyes University",[92,94,95],{"name":93,"class":6},"Sakarya University",{"name":64,"class":6},{"name":96,"class":97},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV","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":109,"type":110},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.",[114],"Multiple Sclerosis",[114,116,117,118],"Teriflunomide","Fatigability","Real-world study","NOT_YET_RECRUITING","2025-11-18",{"date":122,"type":123},"2025-11-21","ACTUAL",{"date":125,"type":110},"2025-11-20",{"date":127,"type":110},"2027-06-15",{"name":5,"class":6},1]