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

Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-11-19
Last Posted Date
2021-06-22
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
18
Registration Number
NCT03745586
Locations
🇨🇭

University Hospital Bern, Inselspital, Bern, Switzerland

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

First Posted Date
2018-11-09
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Korea, Inc.
Target Recruit Count
21
Registration Number
NCT03737708
Locations
🇰🇷

Site KR82003, Daegu, Korea, Republic of

🇰🇷

Site KR82007, Daegu, Korea, Republic of

🇰🇷

Site KR82002, Incheon, Korea, Republic of

and more 7 locations

Tocilizumab Plus a Short Prednisone Taper for GCA

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-10-31
Last Posted Date
2022-12-02
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT03726749
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

First Posted Date
2018-10-09
Last Posted Date
2023-04-19
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
29
Registration Number
NCT03699631
Locations
🇺🇸

Froedtert Hospital, Milwaukee, Wisconsin, United States

Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

First Posted Date
2018-09-19
Last Posted Date
2024-10-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
188
Registration Number
NCT03677154
Locations
🇺🇸

Fort Wayne Medical Institute, Fort Wayne, Indiana, United States

🇺🇸

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

🇺🇸

University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States

and more 50 locations

A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

First Posted Date
2018-09-19
Last Posted Date
2024-12-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
117
Registration Number
NCT03677141
Locations
🇺🇸

University of Alabama Birmingham, Birmingham, Alabama, United States

🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

University of California; Moores Cancer Center, La Jolla, California, United States

and more 38 locations

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

First Posted Date
2018-09-14
Last Posted Date
2024-11-28
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
422
Registration Number
NCT03671018
Locations
🇺🇸

University of Pittsburgh - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Miami Miller School of Medicine, Miami, Florida, United States

🇺🇸

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

and more 26 locations

Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant

First Posted Date
2018-07-17
Last Posted Date
2021-10-11
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
2
Registration Number
NCT03588936
Locations
🇺🇸

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors

First Posted Date
2018-05-29
Last Posted Date
2020-09-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
26
Registration Number
NCT03539484
Locations
🇨🇦

Princess Margaret Cancer Center, Toronto, Ontario, Canada

🇪🇸

Clinica Universitaria de Navarra, Pamplona, Navarra, Spain

🇪🇸

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, Spain

and more 3 locations

An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2018-05-23
Last Posted Date
2024-10-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
211
Registration Number
NCT03533283
Locations
🇧🇪

UZ Gent, Gent, Belgium

🇺🇸

Novant Health Cancer Institute, Charlotte, North Carolina, United States

🇩🇰

Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, Denmark

and more 17 locations
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