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

Clinical Trials

Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Not Applicable

Suspended

Conditions: Pneumonia, Viral
Cytokine Storm

Interventions: Radiation: Ultra-Low-dose radiotherapy
Device: ventilatory support with oxygen therapy
Drug: Lopinavir/ritonavir
Drug: Hydroxychloroquine
Drug: Azithromycin
Drug: Piperacillin/tazobactam
Drug: Low molecular weight heparin
Drug: Corticosteroid injection
Drug: Tocilizumab

First Posted Date: 2020-05-19

Last Posted Date: 2022-03-29

Lead Sponsor: Fundacion GenesisCare

Target Recruit Count: 15

Registration Number: NCT04394182

Locations: 🇪🇸
Hospital La Milagrosa, GenesisCare, Madrid, Spain
🇪🇸
Hospital Vithas Valencia Consuelo, Valencia, Spain

Randomised Evaluation of COVID-19 Therapy

First Posted Date: 2020-05-11

Last Posted Date: 2024-01-05

Lead Sponsor: University of Oxford

Target Recruit Count: 70000

Registration Number: NCT04381936

Locations: 🇻🇳
Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam
🇬🇭
Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana
🇮🇳
Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India

and more 4 locations

The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation

Phase 4

Conditions: Covid19 Pneumonia

Interventions: Drug: Tocilizumab

First Posted Date: 2020-05-06

Last Posted Date: 2020-05-06

Lead Sponsor: Hadassah Medical Organization

Target Recruit Count: 500

Registration Number: NCT04377750

Locations: 🇮🇱
Hadassah Medical Orginisation, Jerusalem, Please Select:, Israel
🇮🇱
Barzilai Medical Center, Ashkelon, Israel
🇮🇱
Wolfson Medical Center, H̱olon, Israel

and more 1 locations

Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection

Phase 2

Terminated

Conditions: COVID-19

Interventions: Drug: Tocilizumab

First Posted Date: 2020-05-06

Last Posted Date: 2023-06-05

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 9

Registration Number: NCT04377659

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Study of Rituximab or Tocilizumab for Patients with Steroid-Dependent Immune-Related Adverse Events (irAEs)

Phase 2

Recruiting

Conditions: Immune-related Adverse Events
Advanced Solid Tumor

Interventions: Drug: Tocilizumab
Drug: Rituximab

First Posted Date: 2020-05-05

Last Posted Date: 2024-12-16

Lead Sponsor: Columbia University

Target Recruit Count: 30

Registration Number: NCT04375228

Locations: 🇺🇸
Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center, New York, New York, United States

A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

Phase 3

Completed

Conditions: COVID-19 Pneumonia

Interventions: Drug: Placebo
Drug: Tocilizumab

First Posted Date: 2020-05-01

Last Posted Date: 2023-02-10

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 377

Registration Number: NCT04372186

Locations: 🇺🇸
eStudySite, La Mesa, California, United States
🇺🇸
El Centro Regional Medical Center, El Centro, California, United States
🇺🇸
Highland Hospital Oakland, Oakland, California, United States

and more 41 locations

Efficacy of Tocilizumab on Patients With COVID-19

Phase 3

Completed

Conditions: SARS-CoV 2

Interventions: Drug: Placebos
Drug: Tocilizumab

First Posted Date: 2020-04-22

Last Posted Date: 2021-07-27

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 243

Registration Number: NCT04356937

Locations: 🇺🇸
Newton-Wellesley Hospital, Newton, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Phase 2

Completed

Conditions: CoVid 19 Positive

Interventions: Drug: Hydroxychloroquine, Azithromycin
Drug: Hydroxychloroquine, Clindamycin
Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose.
Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose.
Drug: Interferon-Alpha2B
Drug: Hydroxychloroquine, Doxycycline
Drug: Convalescent Serum
Drug: Remdesivir
Drug: Tocilizumab
Drug: Losartan
Drug: Methylprednisolone

First Posted Date: 2020-04-16

Last Posted Date: 2020-11-12

Lead Sponsor: The Camelot Foundation

Target Recruit Count: 1800

Registration Number: NCT04349410

Locations: 🇺🇸
FHHI-OI-Camelot; QME, Los Angeles, California, United States

Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

Phase 2

Terminated

Conditions: COVID-19 Pneumonia

Interventions: Drug: Tocilizumab

First Posted Date: 2020-04-15

Last Posted Date: 2020-06-22

Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Target Recruit Count: 126

Registration Number: NCT04346355

Locations: 🇮🇹
Ospedale di Guastalla, Guastalla, RE, Italy
🇮🇹
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, RE, Italy
🇮🇹
ASST Cremona, Cremona, Italy

and more 22 locations

Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

Phase 3

Conditions: COVID-19

Interventions: Drug: Methylprednisolone
Drug: Tocilizumab

First Posted Date: 2020-04-14

Last Posted Date: 2020-04-14

Lead Sponsor: University of Malaya

Target Recruit Count: 310

Registration Number: NCT04345445

Locations: 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Malaysia

Drug Development Updates

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