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

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2017-03-09
Last Posted Date
2024-12-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
860
Registration Number
NCT03075696
Locations
🇵🇱

Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Terapii Komórkowych i Chorób Wewn?trznych, Wroc?aw, Poland

🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Ingalls Memorial Hospital, Harvey, Illinois, United States

and more 38 locations

A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD

First Posted Date
2017-02-23
Last Posted Date
2024-04-11
Lead Sponsor
Fu-Dong Shi
Target Recruit Count
10
Registration Number
NCT03062579
Locations
🇨🇳

Tianjin Medical University General Hospital, Tianjin, Tianjin, China

Tocilizumab in Patients With Schnitzler's Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-02-08
Last Posted Date
2020-02-17
Lead Sponsor
Karoline Krause
Target Recruit Count
8
Registration Number
NCT03046381
Locations
🇩🇪

Charité - Universitätsmedizin Berlin, Dpt. of Dermatology and Allergy, Berlin, Germay, Germany

ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial

First Posted Date
2016-12-29
Last Posted Date
2021-03-02
Lead Sponsor
Oslo University Hospital
Target Recruit Count
200
Registration Number
NCT03004703
Locations
🇳🇴

Oslo University Hospital, Rikshospitalet, Oslo, Norway

🇳🇴

Oslo University Hospital, Ullevål, Oslo, Norway

🇳🇴

St. Olav Hospital, Trondheim, Norway

Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE)

First Posted Date
2016-12-20
Last Posted Date
2017-04-25
Lead Sponsor
University of Michigan Rogel Cancer Center
Registration Number
NCT02997956
Locations
🇺🇸

The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

First Posted Date
2016-11-15
Last Posted Date
2018-11-14
Lead Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Target Recruit Count
35
Registration Number
NCT02963402
Locations
🇪🇸

Insitut de Recerca Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis

First Posted Date
2016-10-11
Last Posted Date
2024-06-25
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
112
Registration Number
NCT02929251
Locations
🇫🇷

Hopital Pellegrin, Bordeaux, France

🇫🇷

Hopital Saint André - Médecine interne, Bordeaux, France

🇫🇷

HCL - Hôpital de la Croix Rousse - Ophtalmologie, Lyon, France

and more 24 locations

Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-09-20
Last Posted Date
2020-12-04
Lead Sponsor
University Hospital, Brest
Target Recruit Count
113
Registration Number
NCT02908217
Locations
🇫🇷

CIC Besançon, Besançon, France

🇫🇷

Centre hospitalier Sud-Francilien, Corbeil Essonnes, France

🇫🇷

Hôpital européen, Marseille, France

and more 14 locations

Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome

First Posted Date
2016-09-20
Last Posted Date
2021-07-02
Lead Sponsor
University of Pennsylvania
Target Recruit Count
80
Registration Number
NCT02906371
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Ectopic Adipose Tissue, Exercise Training and IL-6

First Posted Date
2016-09-15
Last Posted Date
2024-02-26
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
83
Registration Number
NCT02901496
Locations
🇩🇰

Rigshospitalet, Centre of Inflammation and Metabolism (CIM) Centre for Physical Activity Research (CFAS), Copenhagen, Denmark

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