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Clinical trials for Tocilizumab (RoActemra)

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44396   clinical trials with a EudraCT protocol, of which   7408   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    160 result(s) found for: Tocilizumab (RoActemra). Displaying page 2 of 8.
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    EudraCT Number: 2018-002202-31 Sponsor Protocol Number: BAT-1806-002-CR Start Date*: 2019-03-27
    Sponsor Name:Bio-Thera Solutions, Ltd.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
    Medical condition: Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-004369-42 Sponsor Protocol Number: FKS456-001 Start Date*: 2020-04-27
    Sponsor Name:Fresenius Kabi SwissBioSim GmbH
    Full Title: A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients w...
    Medical condition: Moderately to severely active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) PL (Completed) BG (Completed) CZ (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001154-22 Sponsor Protocol Number: WA42380 Start Date*: 2020-04-06
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA.
    Medical condition: Severe COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) FR (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-004990-42 Sponsor Protocol Number: PMR-SPARE Start Date*: 2017-09-26
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects with New-Ons...
    Medical condition: Polymyalgia rheumatica Polymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly with a peak incidence around 70 years of age. It is clinically characteriz...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001110-38 Sponsor Protocol Number: TOCIVID-19 Start Date*: 2020-03-18
    Sponsor Name:ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    Full Title: Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia
    Medical condition: COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001442-19 Sponsor Protocol Number: IIBSP-COV-2020-23 Start Date*: 2020-04-02
    Sponsor Name:INSTITUT DE RECERCA H. SANTA CREU I SANT PAU
    Full Title: Pilot, randomized, multicenter, open-label clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of SARS-CoV-2 infection (COVID-19)
    Medical condition: COVID19
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001767-86 Sponsor Protocol Number: COVIRL-002 Start Date*: 2020-06-25
    Sponsor Name:University College Dublin
    Full Title: An open-label, multi-centre, randomised trial comparing different doses of single-dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive...
    Medical condition: COVID-19 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001754-25 Sponsor Protocol Number: 371c Start Date*: 2019-11-25
    Sponsor Name:Reade
    Full Title: Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority ...
    Medical condition: rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001760-30 Sponsor Protocol Number: AR/BIOM Start Date*: 2012-11-05
    Sponsor Name:OSSERVATORIO EPIDEMIOLOGICO GISEA
    Full Title: Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001275-32 Sponsor Protocol Number: APPI2-CV-2020-01 Start Date*: 2020-04-03
    Sponsor Name:The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    Full Title: Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients with Severe SARS-CoV-2 Pneumonia: An Open-Label Multicenter Sequential Randomized Controlled Trial
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004848 10070267 SARS virus test positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-003011-12 Sponsor Protocol Number: RR08/8613 Start Date*: 2009-03-30
    Sponsor Name:University of Leeds
    Full Title: Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001754-21 Sponsor Protocol Number: 2020-23 Start Date*: 2020-05-19
    Sponsor Name:Assistance Publique Hôpitaux de Marseille
    Full Title: An open prospective randomized therapeutic trial using ANAKINRA or TOCILIZUMAB alone or in combination with RUXOLITINIB in severe stage 2b and 3 COVID-19 disease
    Medical condition: COVID-19-associated disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004624-30 Sponsor Protocol Number: TOC17_01 Start Date*: 2018-05-16
    Sponsor Name:Linköping University
    Full Title: Modulating proinflammatory processes using tocilizumab in major depressive disorder
    Medical condition: Major depressive disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001145-40 Sponsor Protocol Number: P17-03 Start Date*: 2019-11-06
    Sponsor Name:Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts
    Full Title: French prospective open label phase II randomized non-comparative study of SC tocilizumab associated with IV pulse steroid versus IV pulse steroid alone for the treatment of acute anterior ischemic...
    Medical condition: Giant cell arteritis, acute anterior ischemic optic neuropathy
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10043207 Temporal arteritis PT
    20.1 10015919 - Eye disorders 10030924 Optic ischaemic neuropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-012218-30 Sponsor Protocol Number: ML22648 Start Date*: 2009-10-06
    Sponsor Name:Roche Farmacêutica Química, Lda.
    Full Title: A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 w...
    Medical condition: Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003536-23 Sponsor Protocol Number: SFY13370 Start Date*: 2013-02-20
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intoleran...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) ES (Completed) IT (Completed) SE (Completed) EE (Completed) NO (Completed) FI (Completed) NL (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-000054-22 Sponsor Protocol Number: ML28641 Start Date*: 2013-10-01
    Sponsor Name:Roche Products Limited
    Full Title: OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOI...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003484-38 Sponsor Protocol Number: P120206 Start Date*: 2015-01-22
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10016686 Finger osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002909-23 Sponsor Protocol Number: WA18696 Start Date*: 2005-09-21
    Sponsor Name:F Hoffmann La-Roche AG
    Full Title: Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. Estudio de extensión, a largo plazo, de la seguridad durante el tra...
    Medical condition: Rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SE (Completed) NO (Completed) LT (Completed) CZ (Completed) GB (Completed) DK (Completed) FI (Completed) SI (Completed) IT (Completed) IS (Completed) PT (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2017-001429-41 Sponsor Protocol Number: ML39568 Start Date*: 2017-12-20
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
    Full Title: “TOCIlizumab for difficult-to-treat RETroperitoneal fibrosis. TOCIRET Trial”
    Medical condition: idiopathic retroperitoneal fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10021244 Idiopathic retroperitoneal fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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