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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)

Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial

Phase 2
Terminated
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
Drug: Autologous Hematopoietic Stem Cell Transplantation
First Posted Date
2021-07-21
Last Posted Date
2022-03-16
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Target Recruit Count
1
Registration Number
NCT04971005
Locations
🇩🇪

Universitätsklinikum Mannheim, Mannheim, Germany

🇩🇪

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis

Phase 2
Terminated
Conditions
Secondary-progressive Multiple Sclerosis
Interventions
First Posted Date
2021-06-14
Last Posted Date
2025-05-13
Lead Sponsor
State University of New York at Buffalo
Target Recruit Count
8
Registration Number
NCT04925557
Locations
🇺🇸

University at Buffalo, Buffalo General Hospital, Buffalo, New York, United States

Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.

Phase 4
Terminated
Conditions
Multiple Sclerosis
Radiologically Isolated Syndrome
Interventions
Other: Placebo
First Posted Date
2021-05-07
Last Posted Date
2024-10-09
Lead Sponsor
Yale University
Target Recruit Count
3
Registration Number
NCT04877457
Locations
🇺🇸

Cleveland Clinic Melen Center, Cleveland, Ohio, United States

🇺🇸

Yale University, North Haven, Connecticut, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 1 locations

Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in MS

Active, not recruiting
Conditions
Multiple Sclerosis
First Posted Date
2021-05-05
Last Posted Date
2024-10-15
Lead Sponsor
Dr Recai Turkoglu
Target Recruit Count
30
Registration Number
NCT04874597
Locations
🇹🇷

Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department, Istanbul, Uskudar, Turkey

Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2021-04-22
Last Posted Date
2023-06-15
Lead Sponsor
NYU Langone Health
Target Recruit Count
122
Registration Number
NCT04855617
Locations
🇺🇸

Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, Massachusetts, United States

🇺🇸

NYU Langone Health Multiple Sclerosis Comprehensive Care Center (NYULH MSCCC), New York, New York, United States

Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Interventions
First Posted Date
2020-12-30
Last Posted Date
2024-05-16
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
600
Registration Number
NCT04688788
Locations
🇩🇰

Department of Neurology, Herlev Hospital, Herlev, Denmark

🇩🇰

Department of Neurology, Aalborg University Hospital, Aalborg, Denmark

🇩🇰

Department of Neurology, Aarhus University Hospital, Aarhus, Denmark

and more 8 locations

Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

Completed
Conditions
Relapsing Forms of Multiple Sclerosis
Interventions
First Posted Date
2020-12-21
Last Posted Date
2022-10-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2
Registration Number
NCT04676555
Locations
🇦🇺

Novartis Investigative Site, Parkville, Victoria, Australia

Home Based Infusions for Ocrelizumab

Phase 4
Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-12-02
Last Posted Date
2021-06-10
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
110
Registration Number
NCT04650321
Locations
🇺🇸

Amerita, Centennial, Colorado, United States

Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-11-23
Last Posted Date
2022-03-23
Lead Sponsor
Claudio Gobbi
Target Recruit Count
45
Registration Number
NCT04640818
Locations
🇨🇭

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Ticino, Switzerland

Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease

Phase 3
Active, not recruiting
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2020-10-08
Last Posted Date
2023-08-31
Lead Sponsor
Haukeland University Hospital
Target Recruit Count
214
Registration Number
NCT04578639
Locations
🇳🇴

Haukeland University Hospital, Bergen, Norway

🇳🇴

Nordlandsykehuset HF, Bodø, Norway

🇳🇴

Molde sjukehus, Molde, Norway

and more 12 locations
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