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          Last Updated: 10/31/2025

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          23 clinical trials found

            A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® (EU-authorized and US-licensed) in Participants With Relapsing Multiple Sclerosis (RMS)

            Summary: The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and...

            A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

            Summary: The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

            A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)

            Summary: 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. All participants will be...

            Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial

            Summary: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and the leading cause of severe non-traumatic disability in young people, affecting 110,000 people in France. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the ...

            SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis

            Summary: The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneous (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).

            Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

            Summary: 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 - wi...

            Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)

            Summary: This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, an...

            Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions

            Summary: PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be ...

            Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis

            Summary: B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph node...

            Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

            Summary: The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth an...

            Showing 1-12 of 23

            Last Updated: 10/31/2025