[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651712":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"relapsing remitting multiple sclerosis",null,"Patients with early relapsing-remitting multiple sclerosis enrolled in the study and followed prospectively to determine the occurrence of progression independent of relapse activity (PIRA). Participants will subsequently be classified into PIRA and non-PIRA groups according to the study outcome.",[13],{"name":14,"affiliation":15,"role":16},"omnia A badry, assistant","Assiut University neurology Hospital","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","+201017772726","omniaelbadry952@gmail.com",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"anwar M Ali, Professor","+201030361010","Anwarmoha2006@aun.edu.eg",[27],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Assiut university neurology hospital","Asyut","Asyut Governorate","71515","Egypt","EG",{"type":35,"coordinates":36},"Point",[37,38],31.18368,27.18096,{"lat":38,"lon":37},[41,42],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},{"name":43,"role":19,"phone":24,"phoneExt":10,"email":25},"anwar M Ali, Proffesor",{"type":16,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Omnia Abd El Nasser Badry","Assistant Lecturer","100651712","predictors-of-progression-independent-of-relapse-activity-in-relapsing-remitting-multiple-sclerosis-100651712",false,"NCT07762040","Predictors of Progression Independent of Relapse Activity in Relapsing Remitting Multiple Sclerosis","Predictors of Progression Independent of Relapse Activity in Relapsing Remitting Multiple Sclerosis: Multimodal Prospective Cohort Study at Assiut University Hospital","RRMS","Inclusion Criteria:\n\n* RRMS diagnosis per 2024 McDonald Criteria Disease duration ≤ 5 years from disease onset At least 1 year on disease-modifying therapy (DMT) Age 18-55 years (both sexes) Written informed consent obtained\n\nExclusion Criteria:\n\n* • Alternative diagnosis confirmed (e.g., NMOSD, vasculitis)\n\n  * Confirmed RAW\n  * SPMS or progressive onset at baseline\n  * Any systemic or neurological disorders affecting either mobility or cognition\n  * Psychoactive drug use\n  * Recent optic neuritis within the previous six months.\n  * Any ophthalmological condition known to affect retinal nerve fiber layer (RNFL) or ganglion cell-inner plexiform layer (GCIPL) thickness.\n\nGlaucoma. Diabetic retinopathy. Retinal vascular disease. High myopia (\\>6 diopters). Previous ocular trauma or intraocular surgery (except uncomplicated cataract surgery \\>6 months).\n\nMedia opacity preventing reliable OCT acquisition.\n\n• Incomplete follow up or poor compliance",true,"ALL","18 Years","55 Years",{"count":60,"type":61},180,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this prospective observational cohort study is to determine the frequency of progression independent of relapse activity (PIRA) and identify its clinical, radiological, neuroaxonal, and functional predictors in patients with early relapsing-remitting multiple sclerosis (RRMS). The study aims to facilitate early identification of patients at increased risk of disability progression independent of relapses and to support individualized therapeutic decision-making.\n\nThe main questions it aims to answer are:\n\nWhat is the frequency of PIRA in patients with early RRMS? Which demographic and clinical characteristics are associated with the development of PIRA? Which MRI biomarkers, including lesion burden, brain atrophy, spinal cord involvement, and paramagnetic rim lesions (where available), are associated with PIRA? Can optical coherence tomography (OCT) measurements, including peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGCIPL) thickness, predict PIRA? Are serum biomarkers, including neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), associated with an increased risk of PIRA? Which baseline factors independently predict disability progression?\n\nParticipants will undergo comprehensive baseline and follow-up assessments, including collection of demographic and clinical data, neurological examination with Expanded Disability Status Scale (EDSS) scoring, brain and spinal cord MRI, OCT assessment, laboratory evaluation of serum biomarkers (where available), and validated functional and patient-reported outcome measures. Participants will be followed longitudinally to identify confirmed disability accumulation (CDA) and classify disability progression as PIRA or relapse-associated worsening (RAW).\n\nThe primary outcome is the occurrence of PIRA, defined as confirmed disability accumulation independent of clinical relapses during follow-up. Secondary outcomes include identification of independent clinical, imaging, OCT, and laboratory predictors of PIRA and evaluation of their association with long-term disability progression. The findings may improve early risk stratification and support timely initiation of high-efficacy disease-modifying therapies in patients with early RRMS.",[66],"Multiple Sclerosis","NOT_YET_RECRUITING","2026-08-07",{"date":70,"type":71},"2026-08-13","ACTUAL",{"date":73,"type":61},"2026-09-01",{"date":75,"type":61},"2028-12-01",{"name":5,"class":6},1]