[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"demyelinating-autoimmune-diseases-cns\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:demyelinating-autoimmune-diseases-cns":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100514778","longitudinal-cortical-demyelination-in-multiple-sclerosis-and-related-disorders-100514778",false,"NCT05982925","Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders","Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders","Inclusion Criteria:\n\n* 18 years old\n* able to provide consent in English\n* able to undergo MRI\n\nExclusion Criteria:\n\n* contraindication to MRI\n* pregnancy",true,"ALL","18 Years",{"count":20,"type":21},170,"ESTIMATED","OBSERVATIONAL","In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.",[25,26,27],"Multiple Sclerosis","Neuromyelitis Optica","Demyelinating Autoimmune Diseases, CNS","RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2022-05-06",{"date":36,"type":21},"2034-07-31",{"name":38,"class":39},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100605236","inectolizumab-with-steroid-optimization-in-newly-treated-nmosd-100605236","NCT07159893","Inectolizumab With Steroid Optimization in Newly Treated NMOSD","Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;\n* Male or female,age \\>=18 and \\\u003C=65 years old;\n* EDSS score ≤ 7.5;\n* Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Laboratory abnormalities include: (white blood cell count \\\u003C 3×10⁹\u002FL), (neutrophils \\\u003C 1.5×10⁹\u002FL), (hemoglobin \\\u003C 85 g\u002FL), (platelet count \\\u003C 80×10⁹\u002FL), (serum creatinine \\> 1.5×ULN), (total bilirubin \\> 1.5×ULN), (AST (GOT) \\> 3×ULN), (ALT (GPT) \\> 3×ULN), (alkaline phosphatase \\> 2×ULN).\n* Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.\n* Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.\n* Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.\n* Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.\n* Patients who received a live vaccine, except for the herpes zoster vaccine, within 28 days prior to randomization.\n* Patients who have used rituximab or other monoclonal antibodies within 6 months prior to randomization\n* Patients who have received intravenous immunoglobulin (IVIG) within 28 days prior to randomization.\n* Patients who have undergone hematopoietic stem cell transplantation or lymphocyte irradiation before randomization.\n* Patients who have used immunosuppressive agents such as azathioprine (Azathioprine, AZA, half-life t1\u002F2 = 6 hrs), mycophenolate mofetil (Mycophenolate Mofetil, t1\u002F2 = 16 hrs), leflunomide (Leflunomide, LEF, t1\u002F2 = 14.7 hrs), tacrolimus (Tacrolimus, t1\u002F2 = 43 hrs), teriflunomide (Teriflunomide, t1\u002F2 = 18 days), cyclosporine (Cyclosporin, CsA, t1\u002F2 = 27 hrs), methotrexate (Methotrexate, MTX, t1\u002F2 = 14 hrs), mitoxantrone (Mitoxantrone, NVT, t1\u002F2 = 37 hrs), and cyclophosphamide (Cyclophosphamide, CTX, t1\u002F2 = 6 hrs) before randomization are excluded. Except for leflunomide and teriflunomide, patients can be enrolled if the washout period exceeds five half-lives. For leflunomide and teriflunomide, patients need to undergo cholestyramine washout as follows: take 8 grams of cholestyramine orally three times daily for 11 days. If the 8-gram dose is not tolerated, it can be changed to 4 grams per dose, with the same frequency and duration.\n* Patients who have received any investigational drug within 28 days or five half-lives of the trial drug (whichever is shorter) before randomization.\n* Patients with symptoms of severe mental illness who are clinically unable to co-operate;\n* Patients with malignant tumours.\n* Patients who have experienced any of the following events within 12 weeks prior to randomization: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) Class IV heart failure.\n* Patients with herpes zoster infection, positive for HCV antibodies, or positive for HIV antibodies during the screening period.\n* Patients who are unable to undergo magnetic resonance imaging (MRI) during the trial period.\n* Patients whom the investigator deems unsuitable for participation in the trial.","65 Years",{"count":50,"type":21},25,"INTERVENTIONAL",[53],"NA","Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.\n\nStudy Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.",[26,56,27],"Autoimmune Diseases","NOT_YET_RECRUITING","2025-09-04",{"date":60,"type":32},"2025-09-08",{"date":62,"type":21},"2025-09",{"date":64,"type":21},"2026-09",{"name":66,"class":39},"First Affiliated Hospital of Wenzhou Medical University",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},"100503407","phase-3-non-inferiority-study-of-rituximab-compared-to-ocrelizumab-in-relapsing-ms-100503407","NCT05834855","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing Multiple Sclerosis","Noisy Rebels","Inclusion Criteria:\n\n1. Men and women aged 18 years and older\n2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria\n3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS\n4. Able to understand written and spoken Dutch or English\n5. Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n6. Screening EDSS score ≤ 6.5 .\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.\n2. A diagnosis of primary progressive MS according to the diagnostic criteria.\n3. A diagnosis of not-active secondary progressive MS.\n4. Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and\u002For hepatitis C PCR positivity verified at screening visit.\n5. A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis\n6. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.\n7. Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC\n8. Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC.\n9. WBC \\\u003C 1.5 x 109\u002FL if not caused by a reversible effect of documented ongoing medication. If caused by a reversible effect of documented ongoing medication the WBC count must be \\> 1,5 x 109\u002FL before start of study treatment.\n10. Platelet (thrombocyte) count \\\u003C 100 x 109\u002FL\n11. ALAT and\u002For ASAT more than 2 times the upper normal reference limit (ULN)\n12. Serum creatinine \\> 200 μmol\u002FL\n13. Serum bilirubin \\> ULN\n14. Serum IgG \\\u003C LLN\n15. Pregnant or breast-feeding women\n16. Women of childbearing potential (WOCBP) not able or willing to use highly effective methods of birth control per ICH M3 (R2) that result in failure rate of ≤ 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.\n17. History of serious or life-threatening infusion reaction to OCR or RTX\n18. Treatment with glucocorticoids or ACTH within one month prior to start of study treatment\n\n    Prior\u002FConcomitant Therapy\n19. Previous use of second line MS-therapies cladribine, RTX, alemtuzumab, OCR, ofatumumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects. Mitoxantrone is allowed if used \\> 1 year before enrolment. If any of these medications have been used for indications other than MS, patients can be included if the medications have not been used the year before enrolment. Previous treatment with natalizumab is allowed if the reason to switch was disease activity (so not allowed in for example cases that switch from natalizumab to anti-CD20 therapy because of JCV positivity).\n20. Concomitant use of systemic immunosuppressive medication (except corticosteroids for symptomatic treatment of relapses).\n\n    Prior\u002FConcurrent Clinical Study Experience\n21. Currently enrolled in another investigational device or drug study, or less than 30 days since ending of another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational studies will be allowed to participate.\n\n    Lifestyle\n22. Current alcohol or drug dependencies.\n\n    Diagnostic assessments\n23. Presence of metallic objects implanted in the body, that would preclude the ability of the patient to safely have MRI exams.\n24. Not willing to undergo MRI scans with i.v. gadolinium injections",{"count":76,"type":21},200,[78],"PHASE3","Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy.\n\nObjective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS.\n\nStudy design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months\n\nStudy population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment.\n\nIntervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment).\n\nMain study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints)\n\nNature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.",[25,81,27,82,83,84],"Multiple Sclerosis, Relapsing-Remitting","Autoimmune Diseases of the Nervous System","Nervous System Diseases","Demyelinating Diseases",[86,87,88],"ocrelizumab","rituximab","non-inferiority","2023-04-17",{"date":91,"type":32},"2023-04-28",{"date":93,"type":21},"2023-04",{"date":95,"type":21},"2027-05",{"name":97,"class":39},"Amsterdam UMC, location VUmc"]