MedPath

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 Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Phase 1
Completed
Conditions
COVID-19
Interventions
First Posted Date
2021-12-20
Last Posted Date
2024-04-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
2
Registration Number
NCT05164133
Locations
🇿🇦

Global Clinical Trials Sunnyside, Pretoria, South Africa

🇪🇸

Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia, Esplugues de Llobregat, Barcelona, Spain

🇪🇸

Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria, Madrid, Spain

and more 22 locations

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

Phase 1
Active, not recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2021-12-13
Last Posted Date
2024-10-28
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT05155345
Locations
🇺🇸

Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States

🇵🇱

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz, Poland

🇵🇱

Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych, Poznan, Poland

and more 2 locations

High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19

Phase 4
Withdrawn
Conditions
Cytokine Storm
Corticosteroid
Tocilizumab
COVID-19 Virus Infection
Interventions
First Posted Date
2021-11-24
Last Posted Date
2021-11-24
Lead Sponsor
Marmara University
Registration Number
NCT05133635

A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors

Phase 1
Terminated
Conditions
Solid Tumors
Interventions
Drug: RO7444973
Drug: Tocilizumab
First Posted Date
2021-11-22
Last Posted Date
2023-08-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT05129280
Locations
🇧🇪

UZ Antwerpen, Edegem, Belgium

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇦🇺

Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia

and more 7 locations

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1
Recruiting
Conditions
Chronic Lymphocytic Leukemia
Interventions
First Posted Date
2021-10-25
Last Posted Date
2024-12-30
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
137
Registration Number
NCT05091424
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

Uni of Texas - Md Anderson Cancer Center, Houston, Texas, United States

🇦🇺

Princess Alexandra Hospital Woolloongabba, Woolloongabba, Queensland, Australia

and more 19 locations

Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Not Applicable
Completed
Conditions
COVID-19
Interventions
First Posted Date
2021-10-19
Last Posted Date
2023-11-29
Lead Sponsor
University Hospital of Patras
Target Recruit Count
251
Registration Number
NCT05082714
Locations
🇬🇷

University Hospital of Patras, Department of Respiratory Medicine, Patras, Greece

The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia

Completed
Conditions
COVID-19 Pneumonia
ARDS
Interventions
First Posted Date
2021-09-05
Last Posted Date
2023-04-11
Lead Sponsor
Sciberras, Stephen M.D.
Target Recruit Count
100
Registration Number
NCT05035589
Locations
🇲🇹

Mater Dei Hospital, Imsida, Malta

A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

First Posted Date
2021-07-28
Last Posted Date
2024-12-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
46
Registration Number
NCT04980222
Locations
🇪🇸

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia, Salamanca, Spain

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

Stanford Cancer Center, Palo Alto, California, United States

and more 24 locations

Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma

Phase 2
Active, not recruiting
Conditions
Locally Advanced Bladder Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Melanoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Stage III Urethral Cancer AJCC v8
Locally Advanced Bladder Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Interventions
First Posted Date
2021-06-25
Last Posted Date
2024-05-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
35
Registration Number
NCT04940299
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Safety and Effectiveness Study of Tocilizumab in Patients With Severe COVID-19

Conditions
Severe COVID 19 Pneumonia
Tocilizumab
Interventions
First Posted Date
2021-06-14
Last Posted Date
2021-06-14
Lead Sponsor
Hospital Italiano de Buenos Aires
Target Recruit Count
300
Registration Number
NCT04924829
Locations
🇦🇷

Hospital Italiano de Buenos AIres, Ciudad autónoma de Buenos Aires, Caba, Argentina

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