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 Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-06-27
Last Posted Date
2024-10-09
Lead Sponsor
NYU Langone Health
Target Recruit Count
71
Registration Number
NCT03999749
Locations
🇺🇸

The Angeles Clinic, Los Angeles, California, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

NYU Langone Health, New York, New York, United States

and more 1 locations

Tocilizumab in Children With ACP

Early Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2019-05-31
Last Posted Date
2024-11-18
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
27
Registration Number
NCT03970226
Locations
🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-04-23
Last Posted Date
2021-12-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT03923738
Locations
🇨🇭

Universitätsspital Basel; Rheumatologie, Basel, Switzerland

🇨🇭

Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie, Bern, Switzerland

Use of Tocilizumab Drug Levels to Optimize Treatment in RA

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2019-03-29
Last Posted Date
2024-04-18
Lead Sponsor
Reade Rheumatology Research Institute
Target Recruit Count
98
Registration Number
NCT03895879
Locations
🇳🇱

Reade Rheumatology Research Institute, Amsterdam, Netherlands

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

First Posted Date
2019-03-11
Last Posted Date
2024-08-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
645
Registration Number
NCT03869190
Locations
🇪🇸

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, Spain

🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇨🇳

National Taiwan University Hospital, Yun-Lin Branch, Huwei Township, Taiwan

and more 38 locations

Cell Therapy for Immunomodulation in Kidney Transplantation

First Posted Date
2019-03-08
Last Posted Date
2024-12-02
Lead Sponsor
Thomas Wekerle
Target Recruit Count
12
Registration Number
NCT03867617
Locations
🇦🇹

Medical University of Vienna/Vienna General Hospital, Vienna, Austria

A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma

First Posted Date
2019-03-07
Last Posted Date
2024-08-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
47
Registration Number
NCT03866239
Locations
🇫🇷

Centre Leon Berard; Departement Oncologie Medicale, Lyon, France

🇺🇸

Stanford Comprehensive Cancer Center, Stanford, California, United States

🇪🇸

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, Spain

and more 10 locations

Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy

First Posted Date
2019-01-29
Last Posted Date
2024-08-02
Lead Sponsor
David Oh
Target Recruit Count
68
Registration Number
NCT03821246
Locations
🇺🇸

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

🇺🇸

Alvin J. Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States

Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder

First Posted Date
2018-12-26
Last Posted Date
2024-03-20
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
35
Registration Number
NCT03787290
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis

First Posted Date
2018-12-19
Last Posted Date
2018-12-26
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
80
Registration Number
NCT03781310
Locations
🇮🇱

Department of Rheumatology, Tel Aviv Medical Center, Tel Aviv, Israel

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