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 Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant

First Posted Date
2014-08-01
Last Posted Date
2023-03-09
Lead Sponsor
William R. Drobyski, MD
Target Recruit Count
45
Registration Number
NCT02206035
Locations
🇺🇸

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-06-17
Last Posted Date
2022-02-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
82
Registration Number
NCT02165345
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

🇲🇽

Hospital Infantil de México "Federico Gomez"; Rheumatology, Mexico, Mexico

🇲🇽

Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria, Monterrey, Mexico

and more 28 locations

Tocilizumab for Renal Graft Inflammation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-04-09
Last Posted Date
2021-03-09
Lead Sponsor
Flavio Vincenti
Target Recruit Count
33
Registration Number
NCT02108600
Locations
🇺🇸

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

Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-04-02
Last Posted Date
2020-08-19
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
18
Registration Number
NCT02101333
Locations
🇫🇷

Department of internal medicine, Saint-Antoine, Paris, France

Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-03-27
Last Posted Date
2015-05-05
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
105
Registration Number
NCT02097524

Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis

Phase 4
Conditions
Interventions
First Posted Date
2014-03-14
Last Posted Date
2015-05-22
Lead Sponsor
Spanish Foundation of Rheumatology
Target Recruit Count
122
Registration Number
NCT02087696
Locations
🇪🇸

Hospital Universitario de Canarias, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

🇪🇸

Hospital Universitario Araba (Sede Txagorritxu), Vitoria-Gasteiz, Alava, Spain

🇪🇸

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

and more 17 locations

Allogeneic or Haploidentical Stem Cell Transplant Followed By High-Dose Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

First Posted Date
2014-02-07
Last Posted Date
2018-10-12
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
25
Registration Number
NCT02057770
Locations
🇺🇸

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

AIDS 347: IL-6 Blockade in Treated HIV Infection

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-01-30
Last Posted Date
2024-08-06
Lead Sponsor
Case Western Reserve University
Target Recruit Count
34
Registration Number
NCT02049437
Locations
🇺🇸

Case Clinical Research Site, Cleveland, Ohio, United States

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

First Posted Date
2014-01-28
Last Posted Date
2018-04-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
133
Registration Number
NCT02046616
Locations
🇩🇰

Aalborg Universitetshospital Nord, Reumatologisk Afdeling, Alborg, Denmark

🇩🇰

Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme, Hellerup, Denmark

🇩🇰

Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet, Glostrup, Denmark

and more 24 locations
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