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

A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)

Phase 4

Completed

Conditions: Juvenile Idiopathic Arthritis

Interventions: Drug: Tocilizumab
Drug: NSAIDs
Drug: CSs
Drug: MTX

First Posted Date: 2017-10-04

Last Posted Date: 2024-01-30

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 62

Registration Number: NCT03301883

Locations: 🇨🇳
The First Hospital of Jilin University, Changchun City, China
🇨🇳
Shanghai Children's Medical Center; Renal rheumatology, Shanghai City, China
🇨🇳
Capital Institute of Pediatrics, Beijing City, China

and more 7 locations

A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: Glucocorticoid Agent

First Posted Date: 2017-09-25

Last Posted Date: 2020-05-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 101

Registration Number: NCT03291457

Locations: 🇧🇪
Private Practice Els Van Essche, Bonheiden, Belgium
🇧🇪
Rhumarc sciv sprl, Céroux-Mousty, Belgium
🇧🇪
CHC MontLégia, Liege, Belgium

and more 19 locations

Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Phase 1

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Cevostamab
Drug: Tocilizumab

First Posted Date: 2017-09-07

Last Posted Date: 2024-11-20

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 420

Registration Number: NCT03275103

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇨🇦
Princess Margaret Cancer Center, Toronto, Ontario, Canada

and more 15 locations

Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.

Phase 4

Conditions: Giant Cell Arteritis

Interventions: Drug: Tocilizumab

First Posted Date: 2017-08-09

Last Posted Date: 2017-08-10

Lead Sponsor: Hospital of Prato

Target Recruit Count: 15

Registration Number: NCT03244709

Locations: 🇮🇹
Fabrizio Cantini, Prato, Tuscany, Italy

An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)

Phase 3

Completed

Conditions: Giant Cell Arteritis

Interventions: Drug: Tocilizumab

First Posted Date: 2017-06-28

Last Posted Date: 2020-09-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 3

Registration Number: NCT03202368

Locations: 🇫🇷
Hopital Claude Huriez; Internal Medicine, Lille, France
🇫🇷
Hopital Emile Muller; Medecine Interne, Mulhouse, France
🇫🇷
Hopital La Cavale Blanche; Rhumatologie, Brest, France

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Phase 1

Active, not recruiting

Conditions: Pancreatic Adenocarcinoma

Interventions: Drug: Nab-Paclitaxel
Drug: Gemcitabine
Drug: Cobimetinib
Drug: PEGPH20
Drug: BL-8040
Drug: RO6874281
Drug: Atezolizumab
Drug: Oxaliplatin
Drug: Bevacizumab
Drug: AB928
Drug: Tocilizumab
Drug: Selicrelumab
Drug: Tiragolumab
Drug: Leucovorin
Drug: Fluorouracil

First Posted Date: 2017-06-20

Last Posted Date: 2024-11-08

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 340

Registration Number: NCT03193190

Locations: 🇺🇸
Uni of Chicago Medical Center; Room M454, Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 24 locations

An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: MTX
Drug: Placebo Matched to MTX
Drug: Placebo Matched to Tocilizumab

First Posted Date: 2017-05-16

Last Posted Date: 2023-11-28

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 340

Registration Number: NCT03155347

Locations: 🇨🇳
Peking University People's Hospital, Beijing, China
🇨🇳
Peking University First Hospital, Beijing City, China
🇨🇳
The First Affilliated Hospital of Kunming Medical College, Kunming, China

and more 17 locations

Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab
Drug: Pertuzumab
Drug: Tocilizumab

First Posted Date: 2017-05-01

Last Posted Date: 2021-09-10

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 11

Registration Number: NCT03135171

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Yale University, New Haven, New York, United States
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: NSAIDs

First Posted Date: 2017-04-13

Last Posted Date: 2018-12-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 135

Registration Number: NCT03112213

Locations: 🇩🇪
Praxis Prof. Dr.med. Herbert Kellner, München, Germany
🇩🇪
Rheumazentrum Kupka, Altenburg, Germany
🇩🇪
Praxis für Rheumatologie., Amberg, Germany

and more 24 locations

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Phase 4

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: Etanercept
Drug: Infliximab
Drug: Adalimumab
Drug: Golimumab
Drug: Certolizumab Pegol

First Posted Date: 2017-04-04

Last Posted Date: 2022-09-19

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 208

Registration Number: NCT03100253

Locations: 🇮🇹
Policlinico Sant'Orsola Malpighi, Bologna, Italy
🇮🇹
Azienda Consorziale Ospedaliera Policlinico, Bari, Italy
🇮🇹
Azienda Socio Sanitaria Territoriale - Papa Giovanni XXIII, Bergamo, Italy

and more 19 locations

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