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 Real-Life Human Factors (RLHFs) Validation Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-02-15
Last Posted Date
2019-04-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
91
Registration Number
NCT02682823
Locations
🇺🇸

Metroplex Clinical Research, Dallas, Texas, United States

🇺🇸

Pacific Arthritis Ctr Med Grp, Santa Maria, California, United States

🇺🇸

Valerius Medical Group & Research Ctr of Greater Long Beach, Los Alamitos, California, United States

and more 5 locations

A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-02-09
Last Posted Date
2018-04-19
Lead Sponsor
Papworth Hospital NHS Foundation Trust
Target Recruit Count
29
Registration Number
NCT02676947
Locations
🇬🇧

Papworth Hospital NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom

Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-01-21
Last Posted Date
2020-10-20
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
3
Registration Number
NCT02660528
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2016-01-20
Last Posted Date
2021-02-23
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
16
Registration Number
NCT02659150

Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

First Posted Date
2015-11-18
Last Posted Date
2020-02-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
291
Registration Number
NCT02608112
Locations
🇫🇷

Hopital Jean Minjoz, Besancon, France

🇫🇷

CH de Saint Quentin, Saint Quentin, France

🇫🇷

Cabinet de Rhumatologie MSP de Beaublanc, Limoges, France

and more 67 locations

An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

Completed
Conditions
Interventions
First Posted Date
2015-09-17
Last Posted Date
2018-05-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
140
Registration Number
NCT02552940
Locations
🇧🇪

ASZ Aalst, Aalst, Belgium

🇧🇪

Reumacentrum Genk, Genk, Belgium

🇧🇪

AZ Damiaan, Oostende, Belgium

and more 19 locations

Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2015-07-29
Last Posted Date
2023-08-15
Lead Sponsor
University of Nebraska
Registration Number
NCT02511067

Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-06-22
Last Posted Date
2019-07-30
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
104
Registration Number
NCT02477059
Locations
🇫🇷

Rheumatology department Lariboisiere Hospital, Paris, Ile De France, France

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