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It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\n6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.","From baseline up to approximately 5 years",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Time to 3-month confirmed disability progression (3mCDP) on EDSS","The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\n3mCDP is defined as an increase from baseline in EDSS sustained for at least 3 months.",{"measure":18,"description":19,"timeFrame":12},"Time to 6-month confirmed disability improvement (6mCDI) on EDSS","The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\nA 6mCDI is defined as a decrease from baseline in EDSS sustained for at least 6 months.",{"measure":21,"description":22,"timeFrame":12},"Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)","The T25FW is an ambulation measurement assessing speed of walking: a timed (in seconds) walk of 25 feet (7.62 meters). Longer time indicates poorer lower limb function.\n\n3-month worsening by at least 20% in T25FW is defined as an increase from baseline in T25FW of at least 20% sustained for at least 3 months.",{"measure":24,"description":25,"timeFrame":12},"Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)","The 9-HPT is an objective quantitative test of neurological function. It is measured to assess both right and left arm scores, the metric is the time, in seconds, required to insert and remove 9 pegs. Longer time indicates poorer upper limb function.\n\nA 3-month worsening by at least 20% in 9-HPT is defined as an increase from baseline in 9-HPT of at least 20% sustained for at least 3 months",{"measure":27,"description":28,"timeFrame":12},"Annualized rate of new or enlarging T2 lesions","Number of new or enlarging T2 lesions per year based on MRI",{"measure":30,"description":31,"timeFrame":12},"Annualized rate of brain atrophy","Percentage change in brain volume relative to baseline per year based on MRI assessments",{"measure":33,"description":34,"timeFrame":12},"Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)","The SDMT is a sensitive and specific test to assess information processing speed which is typically affected in cognitively impaired MS participants, The test scoring is calculated based on the number of correct answers in 90 seconds.\n\nA 6-month worsening by at least 4 points in SDMT is defined as an increase from baseline in SDMT of at least 4 points sustained for at least 6 months.",{"measure":36,"description":37,"timeFrame":12},"Number of participants with Adverse events and Serious adverse events (SAE)","Incidence of adverse events including changes in laboratory data, vital signs, electrocardiogram (ECG) and Columbia Suicide Severity Rating Scale (C-SSRS) qualifying and reported as AEs.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":45,"whoMasked":46},"QUADRUPLE","Double blind on Core part and Open label on Extension part",[47,48,49,50],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.\n\nThe study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.",[53,60],{"label":54,"type":55,"description":56,"interventionNames":57},"Remibrutinib (LOU064)","EXPERIMENTAL","Core Part: Remibrutinib film-coated tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\\]",[58,59],"Drug: Remibrutinib (blinded)","Drug: Remibrutinib (Open label)",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo","PLACEBO_COMPARATOR","Core Part: Matching placebo film-coated tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\\]",[65,59],"Drug: Placebo",[67,74,77],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","Remibrutinib (blinded)","Remibrutinib (Blinded) active 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Amjad",{"facility":253,"status":93,"city":237,"state":238,"zip":254,"country":97,"countryCode":98,"cosmosGeoPoint":255,"geoPoint":257,"contacts":258},"Medstar Washington Hosp Ctr","20010",{"type":100,"coordinates":256},[242,243],{"lat":243,"lon":242},[259,263],{"name":260,"role":85,"phone":261,"phoneExt":38,"email":262},"Anu Bhooshan","+1 202 877 7000","anu.r.bhooshan@medstar.net",{"name":264,"role":112,"phone":38,"phoneExt":38,"email":38},"Brian Barry",{"facility":266,"status":93,"city":267,"state":268,"zip":269,"country":97,"countryCode":98,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Neurology of Central FL Res Ctr","Altamonte Springs","Florida","32714",{"type":100,"coordinates":271},[272,273],-81.36562,28.66111,{"lat":273,"lon":272},[276,280],{"name":277,"role":85,"phone":278,"phoneExt":38,"email":279},"Adiana Perez","+1 407 790 4990","adiresearchcfl@gmail.com",{"name":281,"role":112,"phone":38,"phoneExt":38,"email":38},"Alicia V 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Brugal",{"facility":346,"status":93,"city":347,"state":268,"zip":348,"country":97,"countryCode":98,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Aqualane Clinical Research","Naples","34105",{"type":100,"coordinates":350},[351,352],-81.79596,26.14234,{"lat":352,"lon":351},[355,359],{"name":356,"role":85,"phone":357,"phoneExt":38,"email":358},"Felicity Schlonsky","+1 239 434 0332","felicity@aqualaneresearch.com",{"name":360,"role":112,"phone":38,"phoneExt":38,"email":38},"Matthew J Baker",{"facility":362,"status":93,"city":363,"state":268,"zip":364,"country":97,"countryCode":98,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Orlando Health Clinical Trials","Orlando","32806",{"type":100,"coordinates":366},[367,368],-81.37924,28.53834,{"lat":368,"lon":367},[371,375],{"name":372,"role":85,"phone":373,"phoneExt":38,"email":374},"Charlene Carlo","+1 321 841 3686","Charlene.carlo@orlandohealth.com",{"name":376,"role":112,"phone":38,"phoneExt":38,"email":38},"Amparo 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