MedPath

Ocrelizumab

Generic Name
Ocrelizumab
Brand Names
Ocrevus
Drug Type
Biotech
CAS Number
637334-45-3
Unique Ingredient Identifier
A10SJL62JY
Background

Ocrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with primary progressive or relapsing forms of multiple sclerosis (MS). It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets B-cells that express the CD20 antigen. Compared to non-humanized CD20 antibodies such as rituximab, ocrelizumab is expected to be less immunogenic with repeated infusions, improving the benefit-to-risk profile for patients with MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that leads to neurological disabilities and a significantly reduced quality of life. Most patients with MS experience episodes of relapses with worsening function, followed by recovery periods or remissions. Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the overall population of patients with MS, and leads to the gradual worsening of neurologic disability from symptom onset, often without early relapses or remissions .

Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevus for intravenous injection. It was later approved by Health Canada in August 2017, making the drug the first available treatment for PPMS in both the US and Canada. In clinical trials of patients with relapsing forms of MS, treatment with ocrelizumab resulted in reduced relapse rates and reduced worsening of disability compared to interferon beta-1a. In phase 3 clinical trials of patients with PPMS, treatment with ocrelizumab led to lower clinical and MRI progression rates compared to placebo.

Indication

用于治疗复发型多发性硬化症(MS)。

Associated Conditions
Clinically Isolated Syndrome (CIS), Primary Progressive Multiple Sclerosis (PPMS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-07-20
Last Posted Date
2025-03-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1710
Registration Number
NCT03593590
Locations
🇦🇹

Landesklinikum Amstetten, Amstetten, Austria

🇦🇹

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck, Innsbruck, Austria

🇦🇹

Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz, Austria

and more 157 locations

A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-07-17
Last Posted Date
2022-01-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
423
Registration Number
NCT03589105
Locations
🇫🇷

CHU de la Timone - Hopital d Adultes; Service de Neurologie, Marseille, France

🇫🇷

Fondation Hopital Saint Joseph; Neurologie, Marseille, France

🇫🇷

Centre hospitalier Annecy Genevois Site St Julien; Neurologie, Metz Tessy, France

and more 43 locations

Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus

Completed
Conditions
Multiple Sclerosis
Pathologic Processes
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Autoimmune Diseases
Primary Progressive Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
First Posted Date
2018-06-20
Last Posted Date
2024-12-10
Lead Sponsor
University of South Florida
Target Recruit Count
18
Registration Number
NCT03562975
Locations
🇺🇸

Carol and Frank Morsani Center for Advanced Healthcare, Tampa, Florida, United States

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Progressive Multiple Sclerosis (PMS)
Interventions
First Posted Date
2018-05-14
Last Posted Date
2025-03-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
927
Registration Number
NCT03523858
Locations
🇫🇷

Hopital Gabriel Montpied CHU de Clermont-Ferrand, Clermont-Ferrand, France

🇫🇷

Hopital B Roger Salengro, Lille, France

🇫🇷

CHU de la Timone - Hopital d Adultes, Marseille, France

and more 122 locations

Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS)

Phase 3
Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-03-26
Last Posted Date
2024-01-09
Lead Sponsor
Haukeland University Hospital
Target Recruit Count
100
Registration Number
NCT03477500
Locations
🇳🇱

VUmc, Amsterdam, Netherlands

🇳🇴

St. Olav's University Hospital, Trondheim, Norway

🇩🇰

Rigshospitalet, Copenhagen, Denmark

and more 5 locations

Mechanism of Action of Ocrelizumab in Multiple Sclerosis

Completed
Conditions
Immune System Diseases
Multiple Sclerosis
Interventions
First Posted Date
2017-11-17
Last Posted Date
2025-02-21
Lead Sponsor
University of Chicago
Target Recruit Count
30
Registration Number
NCT03344094
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Phase 3
Terminated
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2017-03-21
Last Posted Date
2025-01-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1225
Registration Number
NCT03085810
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

🇺🇸

Kane Hall Barry Neurology, Bedford, Texas, United States

🇺🇸

MultiCare Health System Institute for Research and Innovation, Tacoma, Washington, United States

and more 190 locations

Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-01-19
Last Posted Date
2022-03-11
Lead Sponsor
University at Buffalo
Target Recruit Count
30
Registration Number
NCT03025269
Locations
🇺🇸

Jacobs Institute, Buffalo, New York, United States

Safety of Switching From Rituximab to Ocrelizumab in MS Patients

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2016-12-02
Last Posted Date
2021-07-21
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
200
Registration Number
NCT02980042
Locations
🇺🇸

University of Colorado Hospital, Aurora, Colorado, United States

Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Conditions
Multiple Sclerosis
First Posted Date
2016-06-21
Last Posted Date
2017-09-07
Lead Sponsor
Genentech, Inc.
Registration Number
NCT02807285
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Steward St. Elizabeth's Medical Center, Boston, Massachusetts, United States

🇺🇸

University Of Texas Health Science Center Houston, Houston, Texas, United States

and more 53 locations
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