Tocilizumab

Generic Name
Tocilizumab
Brand Names
Actemra, RoActemra, Tyenne, Tofidence
Drug Type
Biotech
Chemical Formula
-
CAS Number
375823-41-9
Unique Ingredient Identifier
I031V2H011
Background

Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.

Indication

Tocilizumab is indicated to treat moderate to severe rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Associated Conditions
Coronavirus Disease 2019 (COVID‑19), Cytokine Release Syndrome caused by CAR-T Cell Therapy, Giant Cell Arteritis (GCA), Juvenile Chronic Polyarthritis, Moderate to Severe Rheumatoid Arthritis, Moderately to Severely Active Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis (SJIA), Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), Active systemic Juvenile idiopathic arthritis, Severe, active Rheumatoid arthritis
Associated Therapies
Monotherapy

Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19

First Posted Date
2020-03-13
Last Posted Date
2020-03-17
Lead Sponsor
Tongji Hospital
Target Recruit Count
120
Registration Number
NCT04306705
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

Ipilimumab, Nivolumab, Tocilizumab and Radiation in Pretreated Patients With Advanced Pancreatic Cancer

First Posted Date
2020-02-06
Last Posted Date
2022-03-31
Lead Sponsor
Herlev Hospital
Target Recruit Count
26
Registration Number
NCT04258150
Locations
🇩🇰

Herlev & Gentofte University Hospital, Denmark, Herlev, Denmark

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

First Posted Date
2020-01-29
Last Posted Date
2024-12-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
237
Registration Number
NCT04246086
Locations
🇺🇸

City of Hope National Medical Center, Duarte, California, United States

🇺🇸

Swedish Medical Center; IDS Pharmacy, Seattle, Washington, United States

🇨🇳

the First Hospital of Jilin University, Changchun, China

and more 20 locations

Tocilizumab REMission in Early RA

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-11-08
Last Posted Date
2019-11-08
Lead Sponsor
University of Leeds
Target Recruit Count
20
Registration Number
NCT04157010
Locations
🇬🇧

Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, United Kingdom

A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

First Posted Date
2019-10-04
Last Posted Date
2020-09-10
Lead Sponsor
Sungkyunkwan University
Target Recruit Count
9508
Registration Number
NCT04115423
Locations
🇰🇷

Sungkyunkwan University, Suwon, Gyeonggi-do, Korea, Republic of

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

First Posted Date
2019-09-12
Last Posted Date
2024-12-04
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
58
Registration Number
NCT04088396
Locations
🇧🇷

Hospital de Clínicas Da Universidade Estadual de Campinas, Campinas, São Paulo, Brazil

🇫🇷

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois, Vandoeuvre lès Nancy, Meurthe-et-Moselle, France

🇯🇵

Institute of Science Tokyo Hospital, Bunkyō, Tokyo, Japan

and more 64 locations

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2019-09-04
Last Posted Date
2024-08-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
498
Registration Number
NCT04077723
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

University of California San Francisco, San Francisco, California, United States

🇧🇪

UZ Gent, Gent, Belgium

and more 14 locations

Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

First Posted Date
2019-08-28
Last Posted Date
2024-06-04
Lead Sponsor
Columbia University
Target Recruit Count
1
Registration Number
NCT04070781
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

🇺🇸

Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States

Treg Modulation With CD28 and IL-6 Receptor Antagonists

First Posted Date
2019-08-26
Last Posted Date
2024-10-09
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT04066114
Locations
🇺🇸

Cleveland Clinic Foundation: Transplantation, Cleveland, Ohio, United States

🇺🇸

University of California San Francisco School of Medicine: Transplantation, San Francisco, California, United States

🇺🇸

University of Alabama School of Medicine: Transplantation, Birmingham, Alabama, United States

and more 4 locations
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