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 Trial of Tocilizumab in ALS Subjects
- Conditions
- Interventions
- First Posted Date
- 2015-06-12
- Last Posted Date
- 2019-12-18
- Lead Sponsor
- Barrow Neurological Institute
- Target Recruit Count
- 22
- Registration Number
- NCT02469896
- Locations
- 🇺🇸
Barrow Neurological Institute, Phoenix, Arizona, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
- First Posted Date
- 2015-05-25
- Last Posted Date
- 2020-03-09
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 212
- Registration Number
- NCT02453256
- Locations
- 🇧🇪
UZ Leuven Gasthuisberg, Leuven, Belgium
🇫🇷Hopital Claude Huriez; Internal Medicine, Lille, France
🇺🇸Joint & Muscle Research Institute, Charlotte, North Carolina, United States
Short-Term Application of Tocilizumab Following Myocardial Infarction
- First Posted Date
- 2015-04-17
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- Keesler Air Force Base Medical Center
- Target Recruit Count
- 28
- Registration Number
- NCT02419937
- Locations
- 🇺🇸
Keesler Medical Center, Keesler Air Force Base, Mississippi, United States
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
- Conditions
- Interventions
- First Posted Date
- 2015-03-31
- Last Posted Date
- 2016-03-28
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 30
- Registration Number
- NCT02404558
- Locations
- 🇯🇵
Investigational Site Number 392001, Sendai-Shi, Japan
🇯🇵Investigational Site Number 392002, Sendai-Shi, Japan
🇯🇵Investigational Site Number 392003, Sendai-Shi, Japan
Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
- First Posted Date
- 2015-03-30
- Last Posted Date
- 2019-12-06
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 353
- Registration Number
- NCT02402686
- Locations
- 🇭🇺
National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department, Budapest, Hungary
🇭🇺Budai Irgalmasrendi Kórház KHT. II. Reumatológia, Budapest, Hungary
🇭🇺Szent Andras Reumakorhaz; Reumatologia, Heviz, Hungary
Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
- Conditions
- Interventions
- First Posted Date
- 2015-03-11
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 18
- Registration Number
- NCT02385110
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept
- Conditions
- Interventions
- First Posted Date
- 2015-02-03
- Last Posted Date
- 2020-10-01
- Lead Sponsor
- Dr. Larry W. Moreland
- Target Recruit Count
- 10
- Registration Number
- NCT02353780
- Locations
- 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
- Conditions
- Interventions
- Biological: Axicabtagene CiloleucelDrug: FludarabineDrug: CyclophosphamideDrug: LevetiracetamDrug: TocilizumabDrug: DexamethasoneDrug: DoxorubicinDrug: High-dose methylprednisoloneDrug: PrednisoneDrug: BendamustineDrug: VincristineDrug: RituximabDrug: IfosfamideDrug: CarboplatinDrug: MethylprednisoloneDrug: EtoposideDrug: GemcitabineDrug: OxaliplatinDrug: Cisplatin
- First Posted Date
- 2015-01-28
- Last Posted Date
- 2024-06-04
- Lead Sponsor
- Kite, A Gilead Company
- Target Recruit Count
- 307
- Registration Number
- NCT02348216
- Locations
- 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸University of California Los Angeles (UCLA), Santa Monica, California, United States
🇨🇦Princess Margaret, Toronto, Ontario, Canada
A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities
- Conditions
- Interventions
- First Posted Date
- 2015-01-12
- Last Posted Date
- 2021-04-08
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 38
- Registration Number
- NCT02336048
- Locations
- 🇪🇸
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, Spain
🇪🇸Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, Spain
🇮🇹Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy
A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2014-12-24
- Last Posted Date
- 2020-04-17
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 149
- Registration Number
- NCT02324257
- Locations
- 🇺🇸
Cedars Sinai Medical Center; Samuel-Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
🇪🇸START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, Spain
🇺🇸Stanford University, Palo Alto, California, United States
Drug Development Updates
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