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

Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Completed
Conditions
Interventions
First Posted Date
2016-09-05
Last Posted Date
2016-09-05
Lead Sponsor
University Hospital, Brest
Target Recruit Count
40
Registration Number
NCT02888496
Locations
🇫🇷

CHRU de Brest, Brest, France

Tocilizumab in Schizophrenia

First Posted Date
2016-08-22
Last Posted Date
2023-07-21
Lead Sponsor
Brian Miller
Target Recruit Count
20
Registration Number
NCT02874573
Locations
🇺🇸

Augusta University, Augusta, Georgia, United States

Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-07-26
Last Posted Date
2018-02-13
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
109
Registration Number
NCT02843789
Locations
🇫🇷

University Hospital, Besançon, France

Treatment Tapering in JIA With Inactive Disease

First Posted Date
2016-07-21
Last Posted Date
2021-04-01
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
62
Registration Number
NCT02840175
Locations
🇫🇷

Necker Children's Hospital, Paris, France

Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Completed
Conditions
Interventions
First Posted Date
2016-06-22
Last Posted Date
2016-10-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
850
Registration Number
NCT02809833

A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

First Posted Date
2016-06-13
Last Posted Date
2023-01-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
48950
Registration Number
NCT02797769

Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers

First Posted Date
2016-05-20
Last Posted Date
2019-09-26
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Target Recruit Count
66
Registration Number
NCT02778789
Locations
🇩🇪

University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology, Erlangen, Germany

Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients

First Posted Date
2016-05-10
Last Posted Date
2023-09-22
Lead Sponsor
Herlev Hospital
Target Recruit Count
147
Registration Number
NCT02767557
Locations
🇳🇴

Department of Oncology, Oslo, Norway

🇩🇰

Herlev & Gentofte University Hospital, Denmark, Herlev, Denmark

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Phase 3
Recruiting
Conditions
Interventions
Other: No systemic corticosteroid
Other: No antiviral agent for COVID-19
Other: No immune modulation for COVID-19
Drug: Standard course macrolide
Other: No antiviral agent for influenza
Drug: Local standard venous thromboprophylaxis
Other: No immunoglobulin
Other: No simvastatin
Other: No cysteamine
Other: No Immune Modulator for Influenza
Other: No vitamin C
Other: No antiplatelet
Procedure: Clinician-preferred mechanical ventilation strategy
Other: No renin-angiotensin system inhibitor
Other: No endothelial modulator
Drug: Ceftriaxone
Drug: Moxifloxacin or Levofloxacin
Drug: Extended course macrolide
Drug: Fixed-duration Hydrocortisone
Drug: Five-days oseltamivir
Drug: Lopinavir / Ritonavir
Biological: Convalescent plasma
Drug: Angiotensin converting enzyme inhibitor
Drug: Nirmatrelvir/ritonavir
Drug: Therapeutic dose anticoagulation
Procedure: Protocolised mechanical ventilation strategy
Drug: Interferon beta-1a
Drug: Vitamin C
Drug: Simvastatin
Drug: Aspirin
Drug: Eritoran
Drug: Cysteamine
Drug: Imatinib
Drug: Shock-dependent hydrocortisone
Drug: Ten-days oseltamivir
Drug: P2Y12 inhibitor
Drug: Angiotensin Receptor Blockers
Drug: Conventional low dose thromboprophylaxis
Biological: Delayed administration of convalescent plasma
Drug: Piperacillin-tazobactam
Drug: Hydroxychloroquine
Drug: Anakinra
Drug: Apremilast
Drug: Baricitinib
Drug: Remdesivir
Drug: Fixed-duration higher dose Hydrocortisone
Drug: Hydroxychloroquine + lopinavir/ritonavir
Drug: Intermediate dose thromboprophylaxis
Drug: Nirmatrelvir/ritonavir + remdesivir
Drug: ARB + DMX-200
Drug: Ceftaroline
Drug: Baloxavir Marboxil
Drug: Tocilizumab
Drug: Amoxicillin-clavulanate
Drug: Fixed-duration dexamethasone
Drug: Five-days oseltamivir + baloxavir marboxil
Drug: Continuation of therapeutic dose anticoagulation
Drug: Ivermectin
Drug: Sarilumab
Drug: Ten-days oseltamivir + baloxavir marboxil
First Posted Date
2016-04-13
Last Posted Date
2024-07-12
Lead Sponsor
UMC Utrecht
Target Recruit Count
20000
Registration Number
NCT02735707
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

🇺🇸

University of Illinois Health, Chicago, Illinois, United States

🇦🇺

Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

and more 405 locations

Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

Completed
Conditions
Interventions
First Posted Date
2016-03-28
Last Posted Date
2016-07-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
592
Registration Number
NCT02721004
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