Ocrevus clinical trials. Further research should Sep 8, 2025 · This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab. Dec 14, 2020 · OCREVUS, a new FDA-approved treatment for relapsing and primary progressive multiple sclerosis, was supported by DelRicht Research. Oct 2, 2023 · Roche safety data will report pregnancy and infant outcomes from more than 3,200 pregnancies, and separate real-world data on pregnant women in the international MSBase registry will provide insights on the impact of OCREVUS and other disease-modifying therapies on relapses during and post-pregnancy. Mar 26, 2025 · In clinical trials, 6 out of 781 females on Ocrevus developed breast cancer, compared to none in the group taking Rebif or placebo. BN42082 Discover the phase III study of a higher dose of ocrelizumab to evaluate its efficacy, safety and pharmacokinetics versus the approved dose of ocrelizu The journey of Ocrevus from concept to clinical use illustrates significant breakthroughs in the field of MS treatment. The Phase IV CHIMES— (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis)—trial evaluated Genentech’s drug Ocrevus (ocrelizumab) in Black and Hispanic/Latinx Nov 26, 2024 · The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks. Mar 8, 2024 · That’s according to data from the ENHANCE Phase 3b clinical trial (NCT05877963), where patients who switched directly to a one-hour infusion of Briumvi at its recommended 450 mg dose rather than Jul 13, 2023 · OCARINA II is a global Phase III multicentre, randomised study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous formulation of OCREVUS compared Oct 11, 2023 · New safety data from 6,155 patients with 28,269 patient-years of exposure to Ocrevus across 12 clinical trials further support the medicine’s favorable benefit-risk profile, which has remained consistent over 10 years. Read about how it works and the latest clinical trial results. Feb 27, 2025 · Using a clinical cut-off date (CCOD) up to September 2024, new findings from the phase 3 OCARINA II study (NCT05232825) continued to showcase the therapeutic potential of subcutaneous (SC) ocrelizumab (Zunovo; Roche), as patients with multiple sclerosis (MS) expressed a high level of satisfaction with this newer route of administration. In active-controlled clinical trials (Study 1 and Study 2), 825 patients with RMS received OCREVUS 600 mg intravenously every 24 weeks (initial treatment was given as two separate 300 mg infusions at Weeks 0 and 2) [see Clinical Studies (14. Dec 28, 2016 · The results from three Phase III studies of the experimental medication Ocrevus™ (ocrelizumab) were published in the New England Journal of Medicine (NEJM). The primary … Sep 5, 2025 · 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). These findings further demonstrate the consistently favorable benefit:risk profile of Ocrevus over seven years. for treating relapsing and progressive forms of MS, and is now approved in more than 95 countries. Sep 13, 2024 · Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office. Pregnancy outcomes1 As of 28 March 2024, 3,989 pregnancies had been reported in women with MS treated with OCR This is the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS In utero exposure to OCR did not increase the risk of adverse pregnancy or infant outcomes compared with epidemiological background rates of both MS and general populations The rates of MCAs were similar Jun 24, 2024 · The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, and comparable control of clinical (relapses) and radiological (MRI lesions) disease activity. Apr 17, 2024 · Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS April 17, 2024 02: Sep 13, 2024 · Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking. Follow Genentech on X via @Genentech and on LinkedIn as Genentech and keep up to date with AAN 2024 news and updates by using the hashtag #AANAM. GlobalData is the parent company of Clinical Trials Arena. Mar 20, 2025 · Dobson et al. In multiple sclerosis (MS) clinical trials, the incidence of infusion reactions in OCREVUS . Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single Learn more about efficacy outcomes in the ORATORIO clinical study of OCREVUS® (ocrelizumab) for primary progressive multiple sclerosis (PPMS). Apr 2, 2025 · Wednesday, Apr 2, 2025 Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 Apr 3, 2025 · Roche’s Phase III trial examining higher doses of intravenous (IV) Ocrevus (ocrelizumab) as a means of slowing disability progression in patients living with relapsing multiple sclerosis (MS) has not met its primary endpoint. The trials collectively enrolled See why OCREVUS ZUNOVO® (ocrelizumab & hyaluronidase-ocsq) and OCREVUS® (ocrelizumab) may be options for treating relapsing MS (RMS), and learn about OCREVUS clinical trials. Oct 22, 2024 · In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. 4bn by 2029. 1,2 Apr 17, 2025 · Roche has announced that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OCREVUS IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional benefit in slowing disability progression. It has also been shown to be well-tolerated, with the most common side effects being injection reactions. Sep 22, 2024 · TG Therapeutics shares made new 52-week highs this week, helped in part by new Briumvi data presentations at ECTRIMS. Jan 19, 2017 · In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or Learn more about efficacy and safety outcomes in the OPERA I and II and open-label extension (OLE) clinical trials of OCREVUS® (ocrelizumab) for relapsing multiple sclerosis (RMS). Approval for primary progressive multiple sclerosis (PPMS) was based on a randomized, double-blind, placebo-control Phase III clinical trial, ORATORIO. Apr 18, 2024 · Roche has reported data from the Phase III trial of OCREVUS SC in individuals with relapsing or primary progressive multiple sclerosis. 3bn in global sales in 2030. [2] Jul 24, 2025 · This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab. The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Sep 18, 2024 · Clinical trials of intravenous ocrelizumab, the active ingredient in Ocrevus Zunovo, have found that the medication increases the risk of respiratory tract infections, skin infections, and herpes The clinical expert also noted that the CDP end points studied in the pivotal trials are typically used only in clinical trials, as disability progression is evaluated over a much longer period in Canadian clinical practice. PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Relapsing Remitting Multiple Sclerosis (RRMS) OCREVUS (ocrelizumab for injection) is indicated for: the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features (see 14 CLINICAL TRIALS). Further, one-year data from the first-ever clinical trial in Black and Hispanic/Latinx people Mar 28, 2017 · Read about Ocrevus' more than 15-year journey, from an academic "what if" to a game-changing treatment for both relapsing and progressive MS patients. The overall exposure in the 96-week controlled treatment periods was 1448 patient-years. Learn more about this study. The study will compare two treatments: ABP 692 and Ocrevus (also known as ocrelizumab), which are both given as an infusion Apr 10, 2025 · AAN 2025: Ocrevus has positive pregnancy and lactation data for women with MS One in three women diagnosed with MS will subsequently conceive, therefore consideration of the maternal-infant dyad is needed. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. Oct 13, 2023 · Genentech, owned by Roche, has announced new clinical and real-world data for Ocrevus (ocrelizumab) for the treatment of patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). Dec 10, 2024 · Data presented recently from the Oratorio trial analyzed the intention to treat population of PPMS patients and the subgroups of patients with upper extremity functional impairment using the 9HPT; results demonstrated reduction in risk of clinical progression in upper extremity disability in patients treated with Ocrevus compared to placebo. Oct 1, 2023 · Safety outcomes from more than 6,000 patients across 12 OCREVUS clinical trials further support the medicine’s consistent favourable safety profile over 10 years. Results from the company’s ongoing multi-centre, randomised, double-blind Musette trial (NCT04544436) found that Ocrevus failed to show additional benefit in slowing In OCREVUS MS clinical trials, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. CHIMES Mar 4, 2024 · This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Jul 12, 2023 · Your healthcare provider should delay your treatment with Ocrevus until your infection is gone. In a placebo-controlled clinical trial (Study 3), a total of 486 patients with PPMS received one course of OCREVUS (600 mg of OCREVUS administered as two 300 mg infusions two weeks apart) given intravenously every 24 weeks and 239 patients received placebo intravenously [see Clinical Studies (14. The objective of this study was to systematically collate the Jul 31, 2023 · Genentech announced positive results from its Phase III trial, OCARINA II, investigating the efficacy of subcutaneous ocrelizumab, Ocrevus. Feb 7, 2025 · Two similarly designed Phase 3 clinical trials, OPERA I (NCT01247324) and OPERA II (NCT01412333), supported the approval of Ocrevus for relapsing forms of MS. Immune-Mediated Colitis OPERA I and II (RMS): Two randomized, double-blind, double-dummy, active comparator-controlled clinical Immune-mediated trials of identical colitis, design which vs Rebif can present in 1656 as patients a severe (OCREVUS; and acute-onset OPERA form I [n=410], of colitis, OPERA has II been [n=417]; reported Rebif; in In the OCREVUS RMS clinical trials, the percentage of patients who completed the clinical trials at year 2 were: See the OPERA I and II study design for more details on how OCREVUS was studied. Side Effects: Any potential side effects and their occurrence rate in patients using either of the medications. Apr 9, 2025 · What makes Ocrevus a reliable medication for MS? Ocrevus boasts of established efficacy and safety data, having significantly reduced relapse rates, disability progression, and MRI lesions over 7 years of clinical trials and real-world use. Ocrelizumab is a recombinant humanized monoclonal antibody selectively targeting CD20-expressing B cells. But no clinical trial has Recently, ocrelizumab (Ocrevus®) was approved for the treatment of primary progressive multiple sclerosis (PPMS) based on data from the ORATORIO clinical trial. Apr 25, 2025 · Ocrevus treatment trials When nerve cells and neural connections are lost, the brain and its structures shrink faster than what’s typical with aging. Neuromyelitis optica spectrum disorder (NMOSD) Sep 13, 2024 · The FDA has approved a new subcutaneous formulation of ocrelizumab (Ocrevus; Roche), a humanized monoclonal antibody designed to target CD20-positive B cells, as a treatment for relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS), its original indication. The approval is based on the consistent pharmacokinetic exposure data from the Phase III OCARINA II trial, which showed no clinically significant difference in exposure Apr 9, 2024 · Newsome has received personal compensation in the range of $10,000-$49,999 for serving as a Lead PI for Clinical Trial with Roche. Evaluating eficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial Mohammad Jun 7, 2017 · A Phase 3 clinical trial, now recruiting RMS and PPMS patients, will explore spinal fluid biomarkers of Ocrevus to better understand how it works in MS. Real-world data about the clinical effectiveness of ocrelizumab has yet to be gathered. Read about the safety, adverse events, and infusion reactions demonstrated in the OPERA, open-label extension (OLE) clinical trial, and the ORATORIO clinical study for OCREVUS® (ocrelizumab) as a treatment for relapsing and primary progressive multiple sclerosis (RMS & PPMS). Initially emerging from research on Rituximab, another anti-CD20 monoclonal antibody, Ocrevus underwent years of rigorous trials. Oct 26, 2022 · Long-term safety from Ocrevus clinical trials consistent for nine years New safety data as of November 2021 will be presented, representing 5,848 patients with RMS and PPMS and 25,153 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. Apr 7, 2025 · In the Phase III MUSETTE study, a higher dose of intravenous Ocrevus (ocrelizumab) did not provide additional benefit in slowing disability progression compared to the currently approved 600mg dose. Oct 18, 2022 · Long-term data from all Ocrevus clinical trials in relapsing MS (RMS) and primary progressive MS (PPMS) over nine years will reinforce the consistently favorable benefit-risk profile of Ocrevus. Sep 11, 2025 · 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 Ocrevus was approved for use in MS in 2017, and was Roche’s top-selling pharmaceutical in 2022, according to the annual 2022 report, making $6. Oct 10, 2023 · Tuesday, Oct 10, 2023 First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity Black and Hispanic / Latinx people with multiple sclerosis (MS) often experience more severe disease and greater disability Results from the Phase IV CHIMES trial demonstrate safety and efficacy May 29, 2024 · Real-world study results presented at the 2024 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) demonstrated similar persistence and adherence of Kesimpta (ofatumumab; Novartis, East Hanover, NJ) treatment compared with Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) treatment in patients with multiple sclerosis (MS). Oct 12, 2023 · New safety data from 6,155 patients with 28,269 patient-years of exposure to OCREVUS across 12 clinical trials further support the medicine’s favourable benefit-risk profile, which has remained Abstract Ocrelizumab (Ocrevus ®) is an intravenously administered, humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). Ocrevus longer-term safety data New safety data as of January 2020 will be presented, representing 5,680 patients with RMS and PPMS and 18,218 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. The efficacy of ocrelizumab in reducing relapse rates and disease activity in patients with RMS was demonstrated in pivotal trials (versus interferon β Clinical trials on Ocrevus The BLA and MAA for Ocrevus were submitted based on results obtained from a Phase III clinical development programme named ORCHESTRA, which included the OPERA I, OPERA II and ORATORIO trials. The effect of ocrelizumab on primary progressive multiple sclerosis (PPMS) has been evaluated during phase 3 trials that enrolled patients In a placebo-controlled clinical trial (Study 3), a total of 486 patients with PPMS received one course of OCREVUS (600 mg of OCREVUS administered as two 300 mg infusions two weeks apart) given intravenously every 24 weeks and 239 patients received placebo intravenously [see Clinical Studies (14. Dragonfly Research, our research arm, is currently conducting clinical trials for relapsing and progressive forms of multiple sclerosis (MS). However, as with any new treatment, it was unclear how this efficacy would translate into real‐world clinical practice. Abstract Ocrelizumab (Ocrevus ®) is an intravenously administered, humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). In multiple sclerosis (MS) clinical trials, the incidence of infusion reactions in OCREVUS-treated patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to each infusion] was 34-40%, with the highest incidence with the first infusion. Apr 23, 2024 · Subcutaneous Ocrevus can help adults with MS remain free of clinical relapses and new or worsening brain lesions, trial data show. This subgroup analysis assessed the long-term efficacy and In OCREVUS MS clinical trials, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion. The safety and efficacy of OCREVUS for RMS was established in two randomized, double-blind, double-dummy, active comparator-controlled clinical trials of 96 weeks duration. S. According to GlobalData, Ocrevus sales are expected to rise to $7. Feb 19, 2025 · 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). 1)]. We report exploratory analyses from a phase 2 trial on the longest follow-up to date of ocrelizumab-treated patients with relapsing-remitting MS (RRMS). Apr 2, 2025 · MUSETTE trial was designed to determine whether a higher dose of the currently approved OCREVUS IV 600 mg would provide additional benefit to people living Nov 12, 2024 · Proposed biosimilar ocrelizumab (Xacrel; Cinnagen) showed comparability for efficacy, safety, and immunogenicity compared with ocrelizumab (Ocrevus; Genentech). OCREVUS is the only approved treatment for PPMS Find out why OCREVUS may be the right choice for treating your primary progressive multiple sclerosis (PPMS). 24 The Sep 15, 2024 · The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity. In Open-label extension (OLE) studies help inform long-term safety and efficacy of disease-modifying therapies in multiple sclerosis (MS). Additionally, new safety data as of January 2019 were announced, representing 4,611 patients with RMS and PPMS and 14,329 patient years of exposure to Ocrevus, across all Ocrevus clinical trials, and remain consistent with the medicine’s favorable benefit-risk profile. Learn about the twice yearly OCREVUS ZUNOVO (ocrelizumab & hyaluronidase-ocsq) dosing schedule, and find out how to evaluate patients before treatment. Ewa Krzystanek has nothing to disclose. Oct 11, 2023 · One-year data from the trial show that OCREVUS controlled disease activity and disability progression in these populations, demonstrating a safety and efficacy profile consistent with the large body of clinical evidence from other OCREVUS trials. Jan 19, 2017 · In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiple sclerosis in a 2:1 ratio to receive intravenous ocrelizumab (600 mg) or placebo every 24 weeks for at Oct 12, 2023 · Most MS patients treated with a new under-the-skin formulation of Ocrevus had no relapses or new MRI activity over six months, data show. Jul 13, 2023 · Ocrevus was Roche’s blockbuster drug, generating more than $1bn in sales one year following its launch. The results show that after 10 years of continuous Ocrevus treatment, 77% of patients with RMS had no disability progression and 92% of them continued to walk unassisted. The approval from the U. Further research is needed to confirm this risk. Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. 1 Oct 11, 2023 · One-year data from the trial show that OCREVUS controlled disease activity and disability progression in these populations, demonstrating a safety and efficacy profile consistent with the large body of clinical evidence from other OCREVUS trials. Apr 17, 2025 · The primary end point was OCR area under the serum concentration-time curve from day 1 to week 12 (AUC W1‒12); other end points included clinical, biomarker, and pharmacodynamic outcomes and safety data. Marketed as Zunovo, this expands on the administration options of ocrelizumab, which was originally approved in Infusion Reactions OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. See full safety for more information. The FDA approval of Ocrevus for relapsing multiple sclerosis (RMS) was based on two identically designed Phase III double-blind, double-dummy randomized controlled trials, OPERA I and II. Apr 16, 2024 · There are more than 30 ongoing OCREVUS clinical trials designed to help us better understand MS and its progression. An alternate mode of administration can boost its sales further, with GlobalData predicting Ocrevus to remain the top-selling MS drug, generating $6. Aug 25, 2025 · 14. May 11, 2020 · ICH GCP US Clinical Trials Registry Clinical Trial NCT04387734 Effects of Ocrevus in Relapsing Multiple Sclerosis (MOBILE-RMS) April 2, 2025 updated by: Feng Yang, PhD, Georgia State University Nov 3, 2022 · Ocrevus, which works similarly to rituximab, was approved in the U. Oct 29, 2020 · Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up. This clinical trial is focused on studying a condition known as Relapsing-Remitting Multiple Sclerosis (RRMS). Dec 11, 2023 · In October 2023, Genentech announced results from the first-ever clinical trial designed exclusively to enhance the knowledge base supporting the Black and Hispanic population living with multiple sclerosis (MS). Jan 10, 2024 · This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. After several phase II clinical trials 17, 18 reported encouraging results for the efficacy of the anti-CD20 antibody rituximab in patients with MS, trials testing ocrelizumab as a treatment for RRMS were launched. Oct 22, 2024 · The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials. About the subcutaneous formulation of OCREVUS (ocrelizumab) The investigational subcutaneous (SC) formulation combines OCREVUS with Halozyme Therapeutics’ Enhanze® drug delivery technology. Our Commitment to Safety Communication Safety updates from ongoing ocrelizumab clinical trials and post-marketing experience Data is drawn from the experience of patients who have started on ocrelizumab globally (as of March 2024): >350,000 patients (>1,000,000 patient-years), including >9,990 patients from clinical trials and open-label extension 1. Although this study shows the benefit of earlier intervention with ocrelizumab in primary progressive disease, progression remains an important unmet need in multiple sclerosis. Additionally, new safety data presented at AAN representing 4,501 patients with RMS and PPMS and 12,559 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine’s favorable benefit-risk profile. Ocrelizumab is used for the management and treatment of multiple sclerosis (MS). Mar 28, 2017 · Read about how the FDA has approved Ocrevus as the first treatment for both relapsing and primary progressive forms of MS. Apr 22, 2024 · Results from a phase III trial showed that Ocrevus (ocrelizumab) delivered as a subcutaneous injection taking just ten minutes and administered twice-yearly massively curtailed clinical relapses and brain lesions in people with both progressive and relapsing remitting multiple sclerosis (MS). Kesimpta is self-administered subcutaneously Jan 9, 2025 · Data from a systematic review of 30 real-world studies show comparable discontinuation rates of ocrelizumab to those in pivotal clinical trials among patients with different types of multiple News in brief Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered, approximately 10-minute subcutaneous injection approved for both relapsing and primary progressive forms of MS. Feb 19, 2025 · Ocrevus as a first-line treatment for early relapsing MS is better at delaying disease progression than starting with a less effective drug. Jul 20, 2020 · ObjectiveTo assess over 3 years of follow-up the effects of maintaining or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and safety measures in the open-label extension (OLE) phase of the pooled OPERA: I/II studies in relapsing Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. Both studies compared Ocrevus to another MS drug In a placebo-controlled clinical trial (Study 3), a total of 486 patients with PPMS received one course of OCREVUS (600 mg of OCREVUS administered as two 300 mg infusions two weeks apart) given intravenously every 24 weeks and 239 patients received placebo intravenously [see Clinical Studies (14. 1 Relapsing Forms of Multiple Sclerosis (RMS) The efficacy of OCREVUS was demonstrated in two randomized, double-blind, double-dummy, active comparator-controlled clinical trials of Apr 7, 2022 · Nearly three of every four participants in the CONSONANCE clinical trial, which is evaluating Ocrevus (ocrelizumab) in people with primary or secondary progressive multiple sclerosis (MS), showed Aug 18, 2021 · A clinical trial testing Ocrevus on upper limb disability progression in primary progressive multiple sclerosis is recruiting participants. Roche has announced results from the Phase III MUSETTE clinical trial of high-dose Ocrevus Aug 5, 2020 · The trials were conducted in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice 23 and the principles of the Declaration of Helsinki. Nov 15, 2024 · 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 Sep 8, 2020 · Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. This is a type of multiple sclerosis where patients experience episodes of new or increasing symptoms followed by periods of partial or complete recovery. In OCREVUS MS clinical trials, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion. Jun 6, 2017 · Read about ongoing clinical trials that are continuing to gather information about Ocrevus' ability to treat multiple sclerosis. Ocrelizumab was developed for primary progressive and relapsing MS. described pregnancy outcomes of women who were exposed to Ocrevus in clinical trials in multiple sclerois (MS) and postmarketing experience up to March 28, 2024. Oct 12, 2021 · Your healthcare provider should delay your treatment with Ocrevus until your infection is gone. Apr 9, 2025 · Clinical Trials: Ocrevus has shown positive results in Phase 3 trials, indicating its effectiveness in treating MS 4 . PML is a rare brain infection that usually leads to death or severe disability. Find out why TGTX stock is a Strong Buy. May 7, 2021 · A Yale University study, called CELLO, will evaluate short-term use of Ocrevus in preventing MS in radiologically isolated syndrome patients. This approval is backed by a decade of proven safety and efficacy data of Ocrevus ® IV, with over 350,000 people treated globally. Discover the clinical trial for fenebrutinib that studies the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with primary prog Sep 13, 2024 · Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking. It is a second-generation anti-CD20 recombinant monoclonal antibody, which is expected to reduce antigenicity and improve CD20 binding. The efficacy of ocrelizumab in reducing relapse rates and disease activity in patients with RMS was demonstrated in pivotal trials (versus interferon β Abstract Across its clinical development program, ocrelizumab demonstrated efficacy in improving clinical outcomes in multiple sclerosis, including annualized relapse rates and confirmed disability progression. Food and Drug Administration in March 2017 marked a watershed moment. Oct 12, 2023 · Interim results from the CHIMES clinical trial (NCT04377555) presented at the 9th joint meeting of the European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) demonstrated the safety and efficacy of Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) in Black and Hispanic patients for the treatment of relapsing multiple sclerosis (RMS). Brain atrophy, or shrinkage, is often used Jan 30, 2025 · Background and ObjectivesPatients with multiple sclerosis (MS) may demonstrate better disease control when treatment is initiated on high-efficacy disease-modifying therapies (DMTs) from onset. Participate in the clinical trial testing if experimental drug ABP 692 is as effective as Ocrevus® for relapsing-remitting MS. gov on 19/07/2021 with the registration code of NCT04966338. This long-term data provides a sense of reliability and trust in its effectiveness in managing MS. 2)]. Clinical trials have demonstrated that Ocrevus Zunovo has a safety profile consistent with the IV formulation, demonstrating comparable suppression of relapse activity and MRI lesions. See results and understand how OCREVUS was evaluated in a clinical trial. 7bn. Oct 1, 2023 · Sunday, Oct 1, 2023 Genentech to Present New Key Clinical and Real-world Data at ECTRIMS-ACTRIMS 2023 Showcasing Strength of Long-term Outcomes in MS and NMOSD Late-breaking results from Phase III trial of Ocrevus (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitor fenebrutinib in multiple sclerosis (MS) will be presented Jul 13, 2023 · Phase III OCARINA II trial met primary and secondary endpoints OCREVUS twice a year, 10-minute injection has the potential to further improve the Apr 16, 2024 · There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression. tpzuk trkhv uxixy nrjvk qjg yanm aynjo nzrj kyehs jstls