[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsing-remitting-multiple-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsing-remitting-multiple-sclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,67,94,122,155,188,210,235,257,283,302,322,343],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100631642","phase-2-a-study-to-evaluate-pharmacokinetics-safety-tolerability-immunogenicity-and-pharmacodynamic-effects-of-subcutaneous-ocrelizumab-administration-in-children-and-adolescents-with-relapsing-remitting-multiple-sclerosis-rrms-100631642",false,"NCT07503340","A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)","An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis","Operetta III","Inclusion Criteria:\n\n* Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit\n* Body weight ≥25 kg\n* Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 or 2024\n* Neurologic stability for at least 30 days prior to screening, and between screening and baseline\n* Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening\n* Must have received all childhood required vaccinations as per local\u002Fnational recommendations for childhood vaccination against infectious diseases\n\nExclusion Criteria:\n\n* Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study\n* Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS)\n* History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus \\[HIV\\], syphilis, tuberculosis \\[TB\\])\n* Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer\n* History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution\n* Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines\n* Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab\n* Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation\n* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug)","ALL","10 Years","17 Years",{"count":21,"type":22},25,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \\\u003C18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.",[28],"Relapsing-remitting Multiple Sclerosis","NOT_YET_RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":22},"2026-08-01",{"date":37,"type":22},"2031-08-01",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100577300","the-setpoint-system-as-a-pro-remyelination-therapy-for-relapsing-remitting-multiple-sclerosis-a-pilot-study-100577300","NCT06796504","The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study","Inclusion Criteria:\n\n* Age 22-50 years at informed consent.\n* Diagnosis of RRMS by revised 2017 McDonald criteria.\n* Latency delay \\>118 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.\n* Peri-papillary retinal nerve fiber layer (pRNFL) \\> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons).\n* Best corrected high-contrast (HCVA) better than 20\u002F200 Snellen equivalent or letter score of 35\n* Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20\u002F40). (Best corrected LCLA must be worse than best corrected HCVA.)\n* Absence of clinical relapse for at least 12 months prior to informed consent\n* No new lesions or increase in existing lesion volume on most recent clinic brain MRI (must be within 1 year of consent)\n* Taking a stable regimen of disease-modifying therapy (DMT) prior to informed consent. If intermediate-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency DMT, the DMT must have been started and maintained at least one year prior to consent.\n* Score of 2.5 to 6.0 by Expanded Disability Status Scale (EDSS) at baseline, with at least of 2 on the functional systems pyramidal function.\n\nExclusion Criteria:\n\n* Confounding ophthalmologic disease or impairments\u002Fconditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, diabetic and\u002For hypertensive retinopathy, history of detached retina, etc.)\n* Severe myopia defined as a refractive error of -6.00 diopters or more\n* Concurrent neurological disorders, including known moderate or severe cervical myelopathy.\n* Clinical optic neuritis within 6 months before screening.\n* Documented optic neuritis in the qualifying eye greater than 5 years before screening.\n* Steroid treatment for MS symptoms in the 30 days prior to consent\n* Hypersensitivity\u002Fallergy to MRI contrast agents and\u002For unable to perform MRI (e.g., claustrophobia).\n* Regular use of or dependency on nicotine products within the past year.\n* Not a surgical candidate.","22 Years","50 Years",{"count":50,"type":22},60,[52],"NA","The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.",[55],"Relapsing Remitting Multiple Sclerosis","RECRUITING","2026-05-18",{"date":59,"type":33},"2026-05-20",{"date":61,"type":33},"2026-04-17",{"date":63,"type":22},"2030-09-30",{"name":65,"class":40},"SetPoint Medical Corporation",6,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":48,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100632707","phase-2-the-hit-hard-and-hit-early-in-multiple-sclerosis-trial-100632707","NCT07517185","The HIt HArd and hiT Early in Multiple Sclerosis Trial","The HIt HArd and hiT Early in Multiple Sclerosis Trial - HiHat Trial A Phase 2 Study of Sequential Treatment With Rituximab and Cladribine for Relapsing-remitting Multiple Sclerosis","HiHat","Inclusion Criteria:\n\n* Diagnosis of RRMS according to the 2017 revised McDonald criteria,\n* With disease activity within the preceding year in the form of: a clinical relapse, and\u002For evidence of ≥2 T2 lesions on MRI scan, and or presence of gadolinium enhancing lesions on an MRI scan,\n* Age 18 - 50 years (inclusive) of age,\n* Disease duration ≤10 years (since MS diagnosis),\n* EDSS 0 - 5.5 (inclusive),\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of progressive MS,\n* Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and\u002For cladribine,\n* Pregnant or lactating women,\n* Unwilling to use contraception during the treatment period and the first year after completing the treatment course,\n* Patients having contraindication for or otherwise not compliant with MRI investigations,\n* Simultaneous treatment with other immunosuppressive drugs,\n* Infection with human immunodeficiency virus (HIV),\n* Active, severe infections (e.g. hepatitis or tuberculosis),\n* Severe cardiac disorder,\n* Moderate or severe renal impairment (eGFR \\\u003C60).\n* Active malignancy,\n* No prior exposure to varicella virus,\n* Vaccination within 4 weeks of first dose of study medication,\n* Severe psychiatric condition.","18 Years",{"count":50,"type":22},[25],"The HiHat trial is a Phase 2 study aimed at evaluating the safety and feasibility of sequential treatment with rituximab and cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The study follows a prospective, open-label, single-arm design, with 60 RRMS patients receiving both treatments in a controlled regimen: two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. Participants are monitored over 24 months through clinical assessments, MRI, and biomarker analyses. The primary objective is to evaluate whether the rate of serious adverse events (SAE) is acceptably low. Secondary objectives include assessing impacts on MRI lesion count, relapse rates, disability progression, quality of life, and safety.",[28],[81,82],"rituximab","cladribine","2026-04-01",{"date":85,"type":33},"2026-04-08",{"date":87,"type":22},"2026-04-15",{"date":89,"type":22},"2030-12-31",{"name":91,"class":92},"Uppsala University","OTHER",4,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100497560","phase-3-rituximab-versus-ocrelizumab-in-relapsing-remitting-multiple-sclerosis-100497560","NCT05758831","RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.","A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis","TRIO","Inclusion Criteria:\n\n* Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND\u002FOR one new T2 lesion in the last 12 months before inclusion);\n* Age between 18 and 55 years\n* EDSS ≤ 5\n* Brain MRI within 6 months before inclusion\n* For women of childbearing potential\\*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \\\u003C1%, for the duration of the study and until 12 months after last dose administered) \\* A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\nA postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\n* Having signed an informed consent form\n* Patients covered with social insurance\n\nNon-Inclusion Criteria:\n\n* Secondary or primary progressive MS;\n* Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;\n* Previous treatment by fingolimod or natalizumab in the last 4 weeks;\n* Treatment with high dose corticosteroids during the 30 days preceding the inclusion;\n* Occurrence of a relapse less than 30 days before inclusion;\n* Pregnancy or breastfeeding;\n* Other neurologic or systemic disease;\n* Concomitant participation or Participation in another therapeutic trial in the last 6 months;\n* Incapacity to understand or sign the consent form;\n* Contraindication to MRI;\n* Contraindication to anti-CD20 therapies:\n\n  * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization\n  * Active malignancy.\n  * Any ongoing infection\n  * Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease\n  * Positive test for HIV, hepatitis B or C, or tuberculosis\n  * Severe immune deficiency:\n* Lymphopenia grade 3 (0.2 to 0.5 × 10\\^9\u002FL) or higher grades\n* Neutropenia grade 3 (0.5 to 1.0 × 10\\^9\u002FL) or higher grades\n\n  * Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids\n  * AST or ALT \\>=3ULN\n  * Platelet (thrombocyte) count \\\u003C 100 x 10\\^9\u002FL\n* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.","55 Years",{"count":104,"type":22},386,[106],"PHASE3","The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.\n\nDuring the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months).\n\nTwo comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.",[109,28],"Multiple Sclerosis",[109,111],"Relapsing-remitting","2026-01-29",{"date":114,"type":33},"2026-02-02",{"date":116,"type":33},"2023-06-01",{"date":118,"type":22},"2030-05-01",{"name":120,"class":92},"Rennes University Hospital",23,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100512217","study-to-evaluate-the-usability-and-value-of-integrated-digital-solutions-in-medical-care-of-participants-with-multiple-sclerosis-100512217","NCT05949580","Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis","Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)","ILLUMINATE","Inclusion Criteria:\n\n* Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)\n* Have a valid email address (for registration of icompanion ms)\n* Have a definite diagnosis of RRMS\n* Time since MS diagnosis ≥1 year\n* Medical history recorded for at least 1 year before enrollment\n* Expanded Disability Status Scale (EDSS) \\\u003C5.5\n\nExclusion Criteria:\n\n* Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion\n* Inability to complete an MRI\n* Currently involved in an interventional trial\n* Diagnosis of progressive MS (primary progressive multiple sclerosis \\[PPMS\\] or secondary progressive multiple sclerosis \\[SPMS\\])",{"count":131,"type":22},500,"OBSERVATIONAL","The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.\n\nThis is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.",[55],[136,137,109,138,139,140,141,142,143,144,145],"icobrain","icompanion","Medical device","Patient app","Digital","Care management","Magnetic resonance imaging (MRI)","Deep learning","Artificial Intelligence (AI)","Patient Reported Outcomes (PRO)","2026-01-16",{"date":148,"type":33},"2026-01-20",{"date":150,"type":33},"2024-10-21",{"date":152,"type":22},"2028-03-31",{"name":39,"class":40},5,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":102,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":187},"100366158","phase-3-best-available-therapy-versus-autologous-hematopoietic-stem-cell-transplant-for-multiple-sclerosis-beat-ms-100366158","NCT04047628","Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)","A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)","BEAT-MS","Inclusion Criteria:\n\n1. Age 18 to 55 years, inclusive, at the time of the screening Visit -2.\n2. Diagnosis of MS according to the 2017 McDonald Criteria139.\n3. EDSS ≤ 6.0 at the time of randomization (Day 0).\n4. T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.\n5. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria described below:\n\n   1. At least one episode of disease activity must occur following ≥ 1 month of treatment with one of the following: (i) an oral DMT approved by the FDA for the treatment of relapsing MS, or (ii) a monoclonal antibody approved by the FDA for the treatment of relapsing MS, or (iii) rituximab. Qualifying DMTs include: dimethyl fumarate, diroximel fumarate, monomethyl fumarate, teriflunomide, cladribine, daclizumab, ponesimod, siponimod, ozanimod, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab, ublituximab, and ofatumumab, and\n   2. At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and\n   3. At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item c.ii. below):\n\n   i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee (see Section 3.5), and ii. MRI evidence of disease activity must include ≥ 1 unique active lesion on one or more brain or spinal cord MRIs. Detailed MRI reports or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:\n\n1\\. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2).\n\n6\\. Candidacy for treatment with at least one of the following high efficacy BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:\n\n1. No prior disease activity episode, as defined in Inclusion Criterion #5, with the candidate BAT DMT, and\n2. No contraindication to the candidate BAT DMT, and\n3. No treatment with the candidate BAT DMT in the 12 months prior to screening.\n\n   7\\. Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations, ≥ 14 days prior to randomization (Day 0).\n\n   8\\. Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0).\n\n   9\\. Insurance approval for MS treatment with at least one candidate BAT DMT (see Inclusion Criterion #6).\n\n   10\\. Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.\n\n   11\\. Females of childbearing potential (defined in Section 5.4.3.1) and males with female partners of childbearing potential are required to adhere to the contraception provisions of Section 5.4.3.1.\n\n   12\\. For participants who use medicinal or recreational marijuana, willingness to substitute MARINOL® if randomized to AHSCT (Section 5.4.2.6).\n\nExclusion Criteria:\n\n1. Diagnosis of primary progressive MS according to the 2017 McDonald criteria.\n2. History of neuromyelitis optica spectrum disorder or MOG antibody disease.\n3. Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational.\n4. Either of the following within one month prior to randomization (Day 0):\n\n   1. Onset of acute MS relapse, or\n   2. Treatment with intravenous methylprednisolone 1000 mg\u002Fday for 3 days or equivalent.\n5. Initiation of any BAT DMT (see Section 5.2.1) between Visit -2 and randomization (Day 0).\n6. Brain MRI or cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML).\n7. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS).\n8. Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis.\n9. History of sickle cell anemia or other hemoglobinopathy.\n10. Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.\n11. Presence or history of mild to severe cirrhosis.\n12. Hepatic disease with the presence of either of the following:\n\n    1. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin ≥ 3.0 times the ULN in the presence of Gilbert's syndrome, or\n    2. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN.\n13. Positive COVID-19 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0).\n14. Evidence of HIV infection.\n15. Positive QuantiFERON - TB Gold,TB Gold Plus, or T-SPOT®.TB test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test.\n16. Active viral, bacterial, endoparasitic, or opportunistic infections.\n17. Active invasive fungal infection.\n18. Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist.\n19. Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0).\n20. Presence or history of clinically significant cardiac disease including: a. Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions.\n\n    b. Coronary artery disease with a documented diagnosis of either: i. Chronic exertional angina, or ii. Signs or symptoms of congestive heart failure. c. Evidence of heart valve disease, including any of the following: i. Moderate to severe valve stenosis or insufficiency, or ii. Symptomatic mitral valve prolapse, or iii. Presence of prosthetic mitral or aortic valve.\n21. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n22. Impaired renal function defined as eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2, according to the CKD-EPI formula144.\n23. Forced expiratory volume in one second (FEV1) \\\u003C 70% predicted (no bronchodilator).\n24. Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) \\\u003C 70% predicted.\n25. Poorly controlled diabetes mellitus, defined as HbA1c \\> 8%.\n26. History of malignancy, except adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. Malignancies for which the participant is judged to be cured will be considered on an individual basis by the study adjudication committee (see Section 3.5).\n27. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous, systemic sclerosis, rheumatoid arthritis, Sjogren's syndrome, polymyositis, dermatomyositis, mixed connective tissue disease, polymyalgia rheumatica, polychondritis, sarcoidosis, vasculitis syndromes, or unspecified collagen vascular disease.\n28. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer.\n29. Prior history of AHSCT.\n30. Prior history of solid organ transplantation.\n31. Positive pregnancy test or breastfeeding.\n32. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.\n33. Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent.\n34. History of hypersensitivity to rabbit or Escherichia coli-derived proteins.\n35. Any metallic material or electronic device in the body, or other condition that precludes the participant from undergoing MRI with gadolinium administration, as determined by the site radiologist.\n36. Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage.\n37. Presence or history of other neurological disorders, including but not limited to CNS or spinal cord tumor; metabolic or infectious cause of myelopathy; genetically-inherited progressive CNS disorder; CNS sarcoidosis; or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments.\n38. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality.\n39. Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.",{"count":164,"type":22},156,[106],"This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio.\n\nAll participants will be followed for 72 months after randomization (Day 0, Visit 0).",[168,55,169],"Relapsing Multiple Sclerosis","Secondary Progressive Multiple Sclerosis",[171,172,173,174,175,176],"Treatment-Resistant Relapsing Multiple Sclerosis (MS)","Autologous Hematopoietic Stem Cell Transplantation (AHSCT)","Autologous Peripheral Blood Stem Cells (PBMCs) Graft","Best Available Therapy (BAT)","Disease-Modifying Therapy (DMT)","BAT DMT","2026-01-02",{"date":179,"type":33},"2026-01-06",{"date":181,"type":33},"2019-12-19",{"date":183,"type":22},"2029-10",{"name":185,"class":186},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",22,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100561132","understanding-the-durable-effect-concept-of-b-cell-modulating-therapies-100561132","NCT06586177","Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies","REBELLION-MS","Inclusion Criteria:\n\n* Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria\n* Current treatment with B cell modulating therapies or initiation\u002Ftransition to B cell modulating therapies according to the \"Summary of Product Characteristics (SmPC)\"\n* EDSS score of 0.0 to 7.0\n\nExclusion Criteria:\n\n* Previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation or bone marrow transplantation\n* Medical, psychiatric, cognitive, or other conditions that, in the opinion of the investigator, impair the patient's ability to understand the patient information and give informed consent\n* Patients receiving immunosuppressive treatment for conditions other than MS or long-term corticosteroid treatment\n* Patients with confirmed infection by the Human Immunodeficiency Virus or Hepatitis C Virus","60 Years",{"count":197,"type":22},100,"This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - will be collected, along with results from imaging techniques such as Optical Coherence Tomography (OCT) and Magnetic Resonance Imaging (MRI). This clinical data will be combined with immunological analyses, including multidimensional flow cytometry (mFC), bulk RNA sequencing (bulk-Seq), T and B cell receptor sequencing (TCR\u002FBCR-Seq), proteomics, and immunoglobulin analysis. This approach aims to enable a detailed characterization of changes in the immune cell repertoire and their impact on the clinical disease course.",[28],"2025-09-12",{"date":202,"type":33},"2025-09-18",{"date":204,"type":33},"2021-10-27",{"date":206,"type":22},"2028-12-31",{"name":208,"class":92},"Heinrich-Heine University, Duesseldorf",1,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":209},"100345876","phase-1-sizomus-safety-of-ixazomib-targeting-plasma-cells-in-multiple-sclerosis-100345876","NCT03783416","SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis","Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis: A Phase 1b Randomised, Double-blind, Placebo-controlled Trial.","SIZOMUS","Inclusion Criteria:\n\n\\- Each participant must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Male and female patients 18 to 65 years old at screening\n2. Must have a diagnosis of MS, and:\n\n   * Patients with RRMS must be on DMT\n   * Patients with progressive MS must not be on DMT\n3. Participants with RRMS must be on stable DMT (i.e. must not have had a relapse within 1 month prior to the screening visit). Patients on tecfidera, cladribine, ocrelizumab, alemtuzumab, fingolimod or natalizumab must be enrolled with caution, at Chief Investigator's (CI) discretion because of the lymphopenia caused by these drugs and the risk of thrombocytopenia in 1-2 % of people after alemtuzumab\n4. OCB positive CSF either from a previous CSF analysis or from the screening CSF analysis\n5. Able and willing to give written informed consent and comply with protocol requirements with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n6. Agree to the use of effective contraception as follows:\n\n   Female patients must:\n   * Be postmenopausal for at least 1 year before the screening visit (postmenopausal status confirmed by serum Follicle Stimulating Hormone (FSH) and oestrogen levels at screening or from a historical sample), OR\n   * Surgically sterile, OR\n   * If they are of childbearing potential, must agree to practice two effective methods of contraception concurrently from the time of signing the informed consent form until 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception\n\n   Male patients must:\n   * Even if surgically sterilized (post-vasectomy with documentation of azoospermia), agree to practice effective barrier contraception during the entire study treatment period and through to 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception\n7. Clinical laboratory values:\n\n   1. Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL\n   2. Platelet count ≥ 100 x 109\u002FL\n   3. Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN)\n   4. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 × ULN.\n   5. Calculated creatinine clearance ≥ 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* Participants meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n  1. EDSS \\> 8.5 at screening\n  2. MS relapse within 1 month prior to screening\n  3. Female patients who are lactating or have a positive serum pregnancy test at screening\n  4. Major surgery within 14 days before baseline\n  5. Any clinically relevant malignancy or infection, as per CI\u002FPI (or delegate) decision, including a possible diagnosis of multiple myeloma: raised erythrocyte sedimentation rate (ESR) and positive urine Bence Jones protein at screening\n  6. Infection requiring systemic (intravenous) antibiotic therapy or other serious infection within 14 days before study enrolment. Urinary tract infections (UTIs) will be treated prior to baseline and may delay baseline\n  7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months of screening\n  8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong Cytochrome P450 Isoform 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's Wort\n  9. History of active hepatitis B or C virus infection, or human immunodeficiency virus (HIV) positive or positive Tuberculin (TB) ELISPOT. If there is positive TB ELISPOT and the TB team decides to treat as latent TB, participants can be reassessed for inclusion after treatment\n  10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n  11. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing\n  12. Diagnosed or treated for malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection\n  13. Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period\n  14. Participation in other clinical trials involving investigational (unlicensed) medicinal products, licensed medicinal products or alternative medicinal therapies, within 30 days of screening and throughout the duration of this trial. Participation in non-interventional, questionnaire or observational studies whilst enrolled in this study is permitted.\n  15. Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or placebo\n  16. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent\n  17. Any pre-existing central nervous system disease or involvement other than MS\n  18. History of uncontrolled drug or alcohol abuse within 6 months prior to screening.","65 Years",{"count":220,"type":22},72,[222],"PHASE1","The study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS). Participants will receive either ixazomib capsules or placebo capsules for up to 24 months.",[55,225,169],"Primary Progressive Multiple Sclerosis","2025-09-01",{"date":228,"type":33},"2025-09-04",{"date":230,"type":33},"2020-06-15",{"date":232,"type":22},"2026-07-31",{"name":234,"class":92},"Queen Mary University of London",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":209},"100584291","cladribine-tablets-as-an-exit-therapy-strategy-100584291","NCT06887426","Cladribine Tablets as an Exit Therapy Strategy","Cladribine Tablets as an Exit Therapy Strategy: Alternative to Continuing Treatment and Plain Treatment Discontinuation in Ageing Stable RMS Patients","CLADREXIT","Inclusion Criteria:\n\n* Patient ≥45-year-old with RRMS\n* Disease duration ≥10 years\n* No evidence of disease activity ≥5 years under DMT\n* EDSS score between 0 and 6.0 included\n\nExclusion Criteria:\n\n* Progressive form of MS\n* Patients without DMT\n* EDSS score ≥6.5","45 Years",{"count":245,"type":22},450,"The objective of the study is to evaluate the effectiveness of CladT, in terms of disease stability and safety, as the last treatment option in ageing MS patients vs treatment continuation and discontinuation This observational study will use database from local cohorts (from France, Belgium, Switzerland). Patients included must meet the inclusion criteria: RRMS diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new MRI lesion, no EDSS progression) for more than 5 years under a DMT, age≥ 45-year-old.\n\nAnalyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing \u002F stopping current treatments but took CladT as exit therapy. Patients with a minimum of 24 months follow up will be included.\n\nThe investigators will ensure that CladT provide disease stability compared to treatment continuation \u002F discontinuation in ageing MS patients by measuring:\n\n* the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever.\n* the percentage of patients free of EDSS progression confirmed for at least 6 months and until the end of patient follow up.\n* the percentage of patients free of MRI activity, defined as new or enlarged T2 lesions compared with the previous brain MRI scan or gadolinium enhancing T1 lesions.",[109,55,169],"2025-05-27",{"date":250,"type":33},"2025-06-02",{"date":252,"type":22},"2025-06",{"date":254,"type":22},"2025-12",{"name":256,"class":92},"University Hospital, Strasbourg, France",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100589095","administration-of-fingolimod-in-greek-patients-with-multiple-sclerosis-100589095","NCT06949956","Administration of Fingolimod in Greek Patients With Multiple Sclerosis.","Administration of Fingolimod in Greek Patients With Multiple Sclerosis for the Evaluation of the Efficacy and Safety, Based on the Standard Clinical Practice.","FILYRA","Inclusion Criteria:\n\n1. Patients over 18 years of age.\n2. Consent and compliance of participants with the treatments and procedures of the study.\n3. Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.\n4. Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).\n5. Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.\n\nExclusion Criteria:\n\n1. Patients under 18 years of age.\n2. Patients with a contraindication to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).\n3. Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.\n4. Patients participating in another research protocol.",{"count":266,"type":22},140,"The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years.\n\nParticipants who are already taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.",[55],[270,271,272,273],"RRMS","ARR","EDSS","Fingolimod","2025-04-29",{"date":276,"type":33},"2025-05-02",{"date":278,"type":22},"2025-06-01",{"date":280,"type":22},"2027-12-31",{"name":282,"class":40},"Elpen Pharmaceutical Co. Inc.",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":195,"enrollmentInfo":291,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":209},"100567048","rituximab-and-ocrelizumab-in-serum-with-multiple-sclerosis-100567048","NCT06663111","Rituximab and Ocrelizumab in Serum With Multiple Sclerosis","Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)","ROS-MS","Inclusion Criteria:\n\n* Included in OVERLORD-MS (NCT04578639)\n* Willing to attend laboratory for blood sample collection at scheduled time points\n\nExclusion criteria:\n\n\\* Not willing to attend laboratory for blood sample collection at scheduled time points",{"count":50,"type":22},"ROS-MS is a clinical pharmacological substudy to the OVERLORD-MS study (NCT04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.",[55],"2024-10-28",{"date":296,"type":33},"2024-10-29",{"date":298,"type":33},"2021-03-15",{"date":280,"type":22},{"name":301,"class":92},"Haukeland University Hospital",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":308,"sex":17,"minAge":309,"maxAge":48,"enrollmentInfo":310,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":4},"100549587","productive-value-of-sonographic-measurement-of-optic-nerve-in-transitional-multiple-100549587","NCT06435962","Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple","1. inclusion criteria\n\n   1. both sex\n   2. Age group from 15 to 50 yrs\n   3. Patient with RRMS without history of optic neuritis\n2. Exclusion criteria :\n\n   1. History of previous optic neuritis\n   2. Medical illness of eye(e.g. diabetes and hypertension)\n   3. MS patient on fingolimod for 6 months or more\n   4. Relapsing or use of steroid in the past 3 months\n   5. Proved alternative diagnosis (neuromyelitis optica )\n   6. local eye disease or surgery",true,"15 Years",{"count":197,"type":22},"1.to evaluate the potential role of the optic nerve diameter ( OND determined by ultrasonography and and visual nerve function by visual evoked potential as a biomarker of early axonal loss and disability in patients with relapsing remitting multiple sclerosis (RRMS).",[55],"2024-06-02",{"date":315,"type":33},"2024-06-04",{"date":317,"type":22},"2024-08-01",{"date":319,"type":22},"2026-03-01",{"name":321,"class":92},"Assiut University",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":102,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":209},"100508943","phase-3-a-study-to-compare-efficacy-pharmacokinetics-pharmacodynamics-and-safety-of-ct-p53-and-ocrevus-in-patients-with-relapsing-remitting-multiple-sclerosis-100508943","NCT05906992","A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis","A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1\u002F3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis","Inclusion Criteria:\n\n* Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.\n* Patient has evidence of recent MS activity as defined in the study protocol\n* Patient has neurological stability for ≥30 days.\n* Patient with 0 to 6.0 (both inclusive) on the EDSS score.\n\nExclusion Criteria:\n\n* Patient diagnosed with primary or secondary progressive MS.\n* Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.\n* Patient unable to complete or has a contraindication to an MRI\n* Patient with contraindications and\u002For severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.\n* Patient who has currently or history of any of medical conditions described in the study protocol.\n* Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.",{"count":330,"type":22},512,[106],"This is a double-blind, randomized, active-controlled, parallel group, Phase 1\u002F3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.",[28],"2024-05-20",{"date":336,"type":33},"2024-05-22",{"date":338,"type":33},"2024-01-11",{"date":340,"type":22},"2029-01",{"name":342,"class":40},"Celltrion",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":218,"enrollmentInfo":350,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":368,"locationsCount":209},"100408866","investigation-of-subclinical-markers-of-multiple-sclerosis-100408866","NCT04604041","Investigation of Subclinical Markers of Multiple Sclerosis","SUBCLIN-MS","Inclusion Criteria:\n\n* Subjects with a documented diagnosis of relapsing-remitting MS according to the Mc Donald criteria (2005) and with EDSS achievement of 0-3.5 according to the modified Kurtzke's EDSS (Expanded disability status scale) for the assessment of neurological function and incapacity of patients with multiple sclerosis\n\nExclusion Criteria:\n\n* Patients with metals in the body (e.g. pacemaker, dentures)\n* Patients with new pregnancies (verbally confirmed)\n* Patients with new head trauma\n* Subjects unwilling to sign a consent or follow study procedures",{"count":351,"type":22},50,"Transcranial magnetic stimulation (TMS) studies reported consistent and substantial impairments in the central nervous system (CNS) in multiple sclerosis (MS). Studies of peripheral nervous system (PNS) function comprising electromyoneurography (EMNG) reported impairments of the PNS in MS that were less pronounced and inconsistent. Neurophysiological studies are generally small and cross-sectional and with the poor grouping of MS patients according to MS type.\n\nThe objective of the study is to investigate clinical, neurophysiological, and immunological markers in relapsing-remitting MS patients, and in patients with relapsing-remitting MS treated with immunomodulation. The results of the study may contribute to a better understanding of the pathophysiology of multiple sclerosis and can provide guidance in the diagnosis and treatment of patients with relapsing-remitting MS.",[109,55],[355,356,357,358,359,360,361],"multiple sclerosis","relapsing remitting","TMS","Cytometry","ELISA","corticosteroids","immunomodulation","2023-09-28",{"date":364,"type":33},"2023-10-02",{"date":366,"type":33},"2020-11-23",{"date":206,"type":22},{"name":369,"class":92},"University of Split, School of Medicine"]