[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600707":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":44,"locations":45,"responsibleParty":581,"collaborators":584,"id":587,"slug":588,"hasResults":589,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":589,"sex":595,"minAge":596,"maxAge":44,"enrollmentInfo":597,"targetDuration":44,"studyType":600,"phases":601,"briefSummary":603,"conditions":604,"keywords":608,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":622},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Optic Neuritis (ON) \"Rescue PLEX\"","ACTIVE_COMPARATOR","Adult participants presenting within 8 days of symptom onset with severe Optic Neuritis 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Miami","Miami","33136",{"type":55,"coordinates":133},[134,135],-80.19366,25.77427,{"lat":135,"lon":134},[138,142,145],{"name":139,"role":63,"phone":140,"phoneExt":44,"email":141},"Byron Lam, MD","305-326-6021","blam@med.miami.edu",{"name":143,"role":63,"phone":44,"phoneExt":44,"email":144},"Adriana Drada","apd86@med.miami.edu",{"name":139,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":147,"status":48,"city":148,"state":149,"zip":150,"country":52,"countryCode":53,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"University of Illinois Chicago","Chicago","Illinois","60612",{"type":55,"coordinates":152},[153,154],-87.65005,41.85003,{"lat":154,"lon":153},[157,161,165],{"name":158,"role":63,"phone":159,"phoneExt":44,"email":160},"Peter MacIntosh, MD","312-996-9120","pmacint1@uic.edu",{"name":162,"role":63,"phone":163,"phoneExt":44,"email":164},"Bhavana 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University","Indianapolis","Indiana","46202",{"type":55,"coordinates":191},[192,193],-86.15804,39.76838,{"lat":193,"lon":192},[196,200,204],{"name":197,"role":63,"phone":198,"phoneExt":44,"email":199},"Devin Mackay, MD","317-948-5450","ddmackay@iu.edu",{"name":201,"role":63,"phone":202,"phoneExt":44,"email":203},"Amy Perkins","317-278-4214","ajperk@iu.edu",{"name":197,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":206,"status":48,"city":207,"state":208,"zip":209,"country":52,"countryCode":53,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"University of Maryland, Baltimore","Baltimore","Maryland","21201",{"type":55,"coordinates":211},[212,213],-76.61219,39.29038,{"lat":213,"lon":212},[216,220,223],{"name":217,"role":63,"phone":218,"phoneExt":44,"email":219},"Sarah Fredrich, MD","410-328-1885","sfredrich@som.umaryland.edu",{"name":221,"role":63,"phone":218,"phoneExt":44,"email":222},"Kerry 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Center","Jackson","Mississippi","39216",{"type":55,"coordinates":337},[338,339],-90.18481,32.29876,{"lat":339,"lon":338},[342,346,350],{"name":343,"role":63,"phone":344,"phoneExt":44,"email":345},"Melanie Truong-Le, DO, OD","601-984-2040","mtruongle@umc.edu",{"name":347,"role":63,"phone":348,"phoneExt":44,"email":349},"Marcus T Wells, MS","601-984-5046","MWells4@UMC.EDU",{"name":343,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":352,"status":69,"city":353,"state":353,"zip":354,"country":52,"countryCode":53,"cosmosGeoPoint":355,"geoPoint":359,"contacts":44},"NYU Langone Health","New York","10016",{"type":55,"coordinates":356},[357,358],-74.00597,40.71427,{"lat":358,"lon":357},{"facility":361,"status":48,"city":353,"state":353,"zip":362,"country":52,"countryCode":53,"cosmosGeoPoint":363,"geoPoint":365,"contacts":366},"Icahn School of Medicine at Mount Sinai","10029",{"type":55,"coordinates":364},[357,358],{"lat":358,"lon":357},[367,371,375],{"name":368,"role":63,"phone":369,"phoneExt":44,"email":370},"Sammita Satyanarayan, MD","212-241-6854","sammita.satyanarayan@mssm.edu",{"name":372,"role":63,"phone":373,"phoneExt":44,"email":374},"Susan Filomena","212-241-3841","susan.e.filomena@mssm.edu",{"name":368,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":377,"status":48,"city":353,"state":353,"zip":378,"country":52,"countryCode":53,"cosmosGeoPoint":379,"geoPoint":381,"contacts":382},"Columbia University","10032",{"type":55,"coordinates":380},[357,358],{"lat":358,"lon":357},[383,387,391],{"name":384,"role":63,"phone":385,"phoneExt":44,"email":386},"Kiran Kiran, MD","734-717-2160","ktt2115@cumc.columbia.edu",{"name":388,"role":63,"phone":389,"phoneExt":44,"email":390},"Gerome Vallejos","619-882-6469","gbv2110@cumc.columbia.edu",{"name":392,"role":43,"phone":44,"phoneExt":44,"email":44},"Kiran Thakur, MD",{"facility":394,"status":48,"city":353,"state":353,"zip":395,"country":52,"countryCode":53,"cosmosGeoPoint":396,"geoPoint":398,"contacts":399},"Weill Cornell Medical College","10065",{"type":55,"coordinates":397},[357,358],{"lat":358,"lon":357},[400,404,408],{"name":401,"role":63,"phone":402,"phoneExt":44,"email":403},"Marc Dinkin, MD","646-962-2020","mjd2004@med.cornell.edu",{"name":405,"role":63,"phone":406,"phoneExt":44,"email":407},"Jaffer Shah","516-749-0058","jas4041@med.cornell.edu",{"name":401,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":410,"status":48,"city":411,"state":412,"zip":413,"country":52,"countryCode":53,"cosmosGeoPoint":414,"geoPoint":418,"contacts":419},"Duke University Health System","Durham","North Carolina","27710",{"type":55,"coordinates":415},[416,417],-78.89862,35.99403,{"lat":417,"lon":416},[420,424,428],{"name":421,"role":63,"phone":422,"phoneExt":44,"email":423},"Nathan Tagg, 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Sciences University","Portland","Oregon","97239",{"type":55,"coordinates":455},[456,457],-122.67621,45.52345,{"lat":457,"lon":456},[460,464,468],{"name":461,"role":63,"phone":462,"phoneExt":44,"email":463},"Elizabeth Silbermann, MD","515-991-4457","silberme@ohsu.edu",{"name":465,"role":63,"phone":466,"phoneExt":44,"email":467},"Jamie Anderson","503-494-1986","ajamie@ohsu.edu",{"name":461,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":470,"status":48,"city":471,"state":472,"zip":473,"country":52,"countryCode":53,"cosmosGeoPoint":474,"geoPoint":478,"contacts":479},"University of Pittsburgh Medical Center, Magee Hospital","Pittsburgh","Pennsylvania","15213",{"type":55,"coordinates":475},[476,477],-79.99589,40.44062,{"lat":477,"lon":476},[480,484,488],{"name":481,"role":63,"phone":482,"phoneExt":44,"email":483},"Ingrid Loma-Miller, MD","412-641-6600","lomamilleri@upmc.edu",{"name":485,"role":63,"phone":486,"phoneExt":44,"email":487},"Courtney Skasik","717-395-2614","skasikca@upmc.edu",{"name":481,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":490,"status":48,"city":491,"state":492,"zip":493,"country":52,"countryCode":53,"cosmosGeoPoint":494,"geoPoint":498,"contacts":499},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":55,"coordinates":495},[496,497],-86.78444,36.16589,{"lat":497,"lon":496},[500,504,508,509],{"name":501,"role":63,"phone":502,"phoneExt":44,"email":503},"Reid Longmuir, MD","615-936-2020","reid.longmuir@vumc.org",{"name":505,"role":63,"phone":506,"phoneExt":44,"email":507},"Hani Rashed","615-875-8670","hani.rashed@vumc.org",{"name":501,"role":43,"phone":44,"phoneExt":44,"email":44},{"name":510,"role":511,"phone":44,"phoneExt":44,"email":44},"James Eaton, MD","SUB_INVESTIGATOR",{"facility":513,"status":48,"city":514,"state":515,"zip":516,"country":52,"countryCode":53,"cosmosGeoPoint":517,"geoPoint":521,"contacts":522},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":55,"coordinates":518},[519,520],-96.80667,32.78306,{"lat":520,"lon":519},[523,527,531],{"name":524,"role":63,"phone":525,"phoneExt":44,"email":526},"Peter Sguigna, MD","214-645-0286","Peter.Sguigna@UTSouthwestern.edu",{"name":528,"role":63,"phone":529,"phoneExt":44,"email":530},"Taylor Hinojo, MS","214-645-3230","Taylor.Hinojo@UTSouthwestern.edu",{"name":524,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":533,"status":48,"city":534,"state":535,"zip":536,"country":52,"countryCode":53,"cosmosGeoPoint":537,"geoPoint":541,"contacts":542},"University of Utah","Salt Lake City","Utah","84112",{"type":55,"coordinates":538},[539,540],-111.89105,40.76078,{"lat":540,"lon":539},[543,547,551],{"name":544,"role":63,"phone":545,"phoneExt":44,"email":546},"Stacey Clardy, MD","801-585-7575","stacey.clardy@hsc.utah.edu",{"name":548,"role":63,"phone":549,"phoneExt":44,"email":550},"Trieste Francis","801-587-3864","Trieste.Francis@hsc.utah.edu",{"name":544,"role":43,"phone":44,"phoneExt":44,"email":44},{"facility":553,"status":69,"city":554,"state":555,"zip":556,"country":52,"countryCode":53,"cosmosGeoPoint":557,"geoPoint":561,"contacts":44},"University of Virginia","Charlottesville","Virginia","22908",{"type":55,"coordinates":558},[559,560],-78.47668,38.02931,{"lat":560,"lon":559},{"facility":563,"status":48,"city":564,"state":565,"zip":566,"country":52,"countryCode":53,"cosmosGeoPoint":567,"geoPoint":571,"contacts":572},"University of Washington","Seattle","Washington","98195",{"type":55,"coordinates":568},[569,570],-122.33207,47.60621,{"lat":570,"lon":569},[573,577,580],{"name":574,"role":63,"phone":575,"phoneExt":44,"email":576},"Yujie Wang, MD","832-628-3220","yujie@uw.edu",{"name":578,"role":63,"phone":44,"phoneExt":44,"email":579},"Courtney Francis","francis3@uw.edu",{"name":574,"role":43,"phone":44,"phoneExt":44,"email":44},{"type":43,"investigatorFullName":582,"investigatorTitle":583,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"John J Chen","Principal Investigator",[585],{"name":586,"class":6},"Patient-Centered Outcomes Research Institute","100600707","phase-3-treatment-of-inflammatory-myelitis-and-optic-neuritis-with-early-vs-rescue-plasma-exchange-timely-plex-100600707",false,"NCT07100990","Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)","A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)","TIMELY-PLEX","Study Population and Setting\n\nThe proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below:\n\nOptic Neuritis Sub-Trial:\n\nInclusion criteria:\n\n* ≥18 years of age\n* MRI orbits demonstrating evidence of new T2 hyperintensity and\u002For post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis\n* Visual acuity 20\u002F200 or worse\n* Within 8 days of onset of visual symptoms\n* Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the \"Early PLEX\" treatment arm)\n* Able to sign and date informed consent form\n* Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion criteria:\n\n* Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)\n* Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields\n* Pregnancy\n* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding\u002Fcoagulopathy, or sepsis.\n* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and\u002For medical comorbidity)\n* Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)\n* Ongoing\u002Fprior treatment with immune-modulating\u002Fimmunosuppressive therapy including:\n\n  * Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization\n  * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization\n  * Intravenous or subcutaneous immune globulin within 3 months of randomization\n  * Plasma exchange within 3 months of randomization\n  * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization\n  * Teriflunomide use within prior 24 months\n  * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization\n  * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide\n* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)\n\nTransverse Myelitis Sub-Trial:\n\nInclusion criteria:\n\n* ≥18 years of age\n* Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)\n\n  * Development of sensory, motor and\u002For autonomic symptomatology attributable to spinal cord dysfunction\n  * Onset of symptoms to nadir \\>12 hours\n  * Exclusion of extra-axial compressive etiology by neuroimaging\n  * Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI\n* Expanded Disability Status Scale \\[EDSS\\] ≥3.0 (excluding visual and cerebral functional systems)\n* EDSS Pyramidal Functional System Score ≥ 2\n* Within 8 days of onset of motor symptoms\n* Able to initiate PLEX within 48h of the first dose of HDCS (if randomized to the \"Early PLEX\" treatment arm)\n* Able to sign and date informed consent form\n* Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion criteria:\n\n* Pre-existing ambulatory, motor, sensory, or bowel\u002Fbladder disability of any cause that could confound trial assessments\n* Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria (Zalewski et al. JAMA Neurology 2018)\n* History of radiation to the spine\n* Pregnancy\n* High clinical suspicion for infectious etiology of myelitis (e.g., fever, rash or other findings)\n* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding\u002Fcoagulopathy, or sepsis.\n* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and\u002For medical comorbidity)\n* Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer)\n\n  * Ongoing\u002Fprior treatment with immune-modulating\u002Fimmunosuppressive therapy including: Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization\n  * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization\n  * Intravenous or subcutaneous immune globulin within 3 months of randomization\n  * Plasma exchange within 3 months of randomization\n  * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization\n  * Teriflunomide use within prior 24 months\n  * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization\n  * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide\n* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)","ALL","18 Years",{"count":598,"type":599},382,"ESTIMATED","INTERVENTIONAL",[602],"PHASE3","The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.",[605,606,607],"Optic Neuritis","Myelitis","Myelitis, Transverse",[609,610,611,612],"Plasma Exchange","Plasmapheresis","Apheresis","Pheresis","2026-04-29",{"date":615,"type":616},"2026-05-05","ACTUAL",{"date":618,"type":616},"2025-07-11",{"date":620,"type":599},"2031-04-30",{"name":5,"class":6},31]