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

Toclizumam Versus Dexamethasone in Severe Covid-19 Cases

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2020-08-19
Last Posted Date
2020-08-25
Lead Sponsor
South Valley University
Target Recruit Count
69
Registration Number
NCT04519385
Locations
🇪🇬

Qena faculty medicine, Qinā, Egypt

Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan

First Posted Date
2020-07-30
Last Posted Date
2020-07-30
Lead Sponsor
UNICEF
Target Recruit Count
600
Registration Number
NCT04492501
Locations
🇵🇰

Pak Emirates Military Hospital, Rawalpindi, Punjab, Pakistan

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-07-21
Last Posted Date
2024-07-08
Lead Sponsor
University of Chicago
Target Recruit Count
75
Registration Number
NCT04479358
Locations
🇺🇸

University of Chicago Medicine, Chicago, Illinois, United States

Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia

Phase 2
Completed
Conditions
Interventions
First Posted Date
2020-06-24
Last Posted Date
2021-06-02
Lead Sponsor
Fundacion SEIMC-GESIDA
Target Recruit Count
495
Registration Number
NCT04445272
Locations
🇪🇸

Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain

🇪🇸

Hospital Universitario Marqués Valdecilla, Santander, Cantabria, Spain

🇪🇸

Hospital Clínic i Provincial Barcelona, Barcelona, Spain

and more 39 locations

Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS

Phase 3
Conditions
Interventions
First Posted Date
2020-06-02
Last Posted Date
2020-11-17
Lead Sponsor
Queen's Medical Center
Target Recruit Count
300
Registration Number
NCT04412772
Locations
🇺🇸

Queen's Medical Center, Honolulu, Hawaii, United States

A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

First Posted Date
2020-06-01
Last Posted Date
2022-02-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
649
Registration Number
NCT04409262
Locations
🇪🇸

Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain

🇺🇸

Baylor Scott & White Medical Center - Irving, Irving, Texas, United States

🇧🇷

Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia, Curitiba, PR, Brazil

and more 51 locations

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

First Posted Date
2020-05-29
Last Posted Date
2024-10-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
270
Registration Number
NCT04408638
Locations
🇵🇱

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

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Community Cancer Institute (CCI), Fresno, California, United States

and more 64 locations

Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers

First Posted Date
2020-05-27
Last Posted Date
2020-08-26
Lead Sponsor
Beneficência Portuguesa de São Paulo
Target Recruit Count
129
Registration Number
NCT04403685
Locations
🇧🇷

HCOR -Hospital do Coracao, Sao Paulo, SP, Brazil

🇧🇷

Beneficência Portuguesa de Sao Paulo, Sao Paulo, Brazil

🇧🇷

UNIFESP, São Paulo, Sao Paulo, Brazil

and more 4 locations

Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

First Posted Date
2020-05-20
Last Posted Date
2024-08-19
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
21
Registration Number
NCT04395222
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

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