[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556768":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":92,"collaborators":18,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":18,"enrollmentInfo":104,"targetDuration":18,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ozanimod de-escalation of anti-CD20 treatment","EXPERIMENTAL","Ozanimod will be started 6-12 months after the last anti-CD20 infusion, including ocrelizumab subcutaneous injection, or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study.",[13],"Drug: Ozanimod",{"label":15,"type":16,"description":17,"interventionNames":18},"Continued anti-CD20 treatment","NO_INTERVENTION","Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ozanimod","De-escalation of anti-CD20 treatment using ozanimod.",[9],[26],"Zeposia",[28],{"name":29,"affiliation":5,"role":30},"Enrique Alvarez, MD\u002FPhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","303-724-8249","enrique.alvarez@cuanschutz.edu",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"Lilli Farrell, BS","lillian.farrell@cuanschutz.edu",[40,60,77],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-104.83192,39.72943,{"lat":52,"lon":51},[55,56],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":57,"role":33,"phone":58,"phoneExt":18,"email":59},"Haley Steinert","303-724-4644","neuroresearch@cuanschutz.edu",{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Cleveland Clinic","Las Vegas","Nevada","89106",{"type":49,"coordinates":66},[67,68],-115.13722,36.17497,{"lat":68,"lon":67},[71,75],{"name":72,"role":33,"phone":73,"phoneExt":18,"email":74},"Liza Mercurio","725-373-1590","mercurl2@ccf.org",{"name":76,"role":30,"phone":18,"phoneExt":18,"email":18},"Carrie M Hersh, DO",{"facility":61,"status":42,"city":78,"state":79,"zip":80,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Cleveland","Ohio","44195",{"type":49,"coordinates":82},[83,84],-81.69541,41.4995,{"lat":84,"lon":83},[87,91],{"name":88,"role":33,"phone":89,"phoneExt":18,"email":90},"Devon S Conway, MD","216-636-1158","conwayd2@ccf.org",{"name":88,"role":30,"phone":18,"phoneExt":18,"email":18},{"type":93,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100556768","phase-4-prospective-evaluation-of-sequencing-from-anticd-20-therapies-to-ozanimod-100556768",false,"NCT06529406","Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod","Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)","COAST","Inclusion Criteria:\n\n* Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit\n* Male or female participants \\> or = to 18 years of age at the time of initiation of de-escalation\n* Participants do not have evidence of new inflammatory disease activity (no new T2\u002Fcontrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation\n* Participant is taking an anti-CD20 therapy as a DMT continuously for a minimum of two years (e.g., has received at least 3 courses of rituximab, ocrelizumab, ublituximab; 24 months of treatment with ofatumumab; or a combination of treatments whereby the patient has been deemed to be B-cell depleted for 2 years) prior to initiation of de-escalation\n* Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1\n* Participants must provide written informed consent and be able to comply with the visit schedule and study related assessments\n* Participants must be able to undergo a brain MRI without anesthesia\n* Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions.\n\nExclusion Criteria:\n\n* Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS\n* Participant has an EDSS \\>6.5\n* Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)\n* Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening.\n* Participant has any other significant medical or psychiatric illness, if uncontrolled, that could jeopardize a subject's health or put them at significant safety risk during the course of the study in the opinion of treating investigator. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression\n* Participant has a history of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia\u002Fcancer that has been excised and resolved)\n* Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure\n* Participant has Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker\n* Participant has severe untreated sleep apnea\n* Participant has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) \\> 9%, or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy, or a history of uveitis\n* Participant has a history or known presence of recurrent or chronic infection (e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed.\n* Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a confirmed or suspected progressive multifocal leukoencephalopathy (PML). Known currently active tuberculosis (TB). History of incompletely treated Mycobacterium tuberculosis (TB) infection, as indicated by: Subject's medical records documenting incomplete treatment for Mycobacterium TB; Subject's self-reported history of incomplete treatment for Mycobacterium TB; Subjects with a history of TB who have undergone treatment accepted by the local health authorities (within 1 year from screening) may be eligible for study entry.\n\nExclusions related to Medications:\n\n* Concomitant use of a monoamine oxidase inhibitor\n* Use of systemic corticosteroids in the last 2 years, except for the use as a premedication for B-cell depleting treatment (Note: Use of inhaled or topical steroids; use of oral steroids for no greater than 14 days given for a non-MS condition are allowed)\n* Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine, or any experimental MS treatment within 5 half-lives\n* Prior allergy to ozanimod\n\nExclusions related to Laboratory results:\n\n* Participant has IgG levels \\\u003C400 mg\u002FdL\n* Participant has neutrophils \\\u003C 1500\u002FμL (1.5 GI\u002FL)\n* Participant has an absolute white blood cell (WBC) count \\\u003C 3500\u002FμL (3.5 GI\u002FL)\n* Participant has an absolute lymphocyte count (ALC) \\\u003C 800 cells\u002FμL (0.80 GI\u002FL).\n* Participant has liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \\> 3 x the upper limit of normal (ULN)","ALL","18 Years",{"count":105,"type":106},100,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.",[112],"Relapsing Multiple Sclerosis","2025-09-12",{"date":115,"type":116},"2025-09-18","ACTUAL",{"date":118,"type":116},"2024-07-29",{"date":120,"type":106},"2029-08-01",{"name":5,"class":6},3]