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Clinical trials for Sarilumab

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   44341   clinical trials with a EudraCT protocol, of which   7370   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 ).  
     
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    36 result(s) found for: Sarilumab. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-004078-24 Sponsor Protocol Number: SARIPET_2019.099_version_1.1 Start Date*: 2020-05-07
    Sponsor Name:IDIVAL
    Full Title: Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis
    Medical condition: 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 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002988-18 Sponsor Protocol Number: EFC15068 Start Date*: 2018-11-26
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
    Medical condition: Giant Cell Arteritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10018250 Giant cell arteritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) DK (Completed) HU (Completed) FR (Completed) SE (Prematurely Ended) EE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) PT (Completed) SI (Completed) BE (Prematurely Ended) HR (Completed) GB (GB - no longer in EU/EEA) NO (Completed) FI (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019262-86 Sponsor Protocol Number: LTS11210 Start Date*: 2011-06-22
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis...
    Medical condition: Artritis Reumatoide _______________________ Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FI (Completed) EE (Completed) HU (Completed) NL (Completed) DE (Completed) GR (Completed) NO (Completed) LT (Completed) CZ (Completed) IT (Completed) AT (Completed) PT (Completed) SK (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003138-17 Sponsor Protocol Number: P1200_51 Start Date*: 2020-01-17
    Sponsor Name:Cliniques universitaires Saint-Luc
    Full Title: A 24 weeks proof of concept study to evaluate the clinical, MRI and synovial tissue benefit of Sarilumab in active RA patients despite TNF agents
    Medical condition: Medical condition – Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001390-76 Sponsor Protocol Number: ESCAPE Start Date*: 2020-04-27
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patie...
    Medical condition: Covid-19 coronavirus infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004855 10047468 Viral lower respiratory tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002790-22 Sponsor Protocol Number: EFC13752 Start Date*: 2014-06-02
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis
    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: HU (Completed) CZ (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001984-66 Sponsor Protocol Number: EFC11574 Start Date*: 2013-04-25
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adal...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    15.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed) CZ (Completed) ES (Completed) GR (Completed) LT (Prematurely Ended) FI (Completed) LV (Prematurely Ended) IT (Prematurely Ended) NO (Completed)
    Trial results: View results
    EudraCT Number: 2012-004339-21 Sponsor Protocol Number: MSC12665 Start Date*: 2014-05-25
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis W...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-000868-18 Sponsor Protocol Number: 202018 Start Date*: 2019-12-02
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in par...
    Medical condition: Rheumatoid Arthritis
    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: GB (GB - no longer in EU/EEA) DE (Completed) PL (Completed) LT (Completed) ES (Completed) BE (Completed) CZ (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002989-42 Sponsor Protocol Number: EFC15160 Start Date*: 2018-11-29
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica
    Medical condition: Polymyalgia rheumatica
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10036099 Polymyalgia rheumatica PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) DE (Completed) BE (Prematurely Ended) FR (Prematurely Ended) HU (Completed) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) NL (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004845-34 Sponsor Protocol Number: ACT13480 Start Date*: 2013-09-02
    Sponsor Name:Sanofi-aventis recherche et développement
    Full Title: A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients with Non-Infectious, Intermediate, Po...
    Medical condition: Uveitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10015919 - Eye disorders 10046851 Uveitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-002037-15 Sponsor Protocol Number: SARTRE Start Date*: 2020-05-25
    Sponsor Name:Cristina Avendaño Sola
    Full Title: Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
    Medical condition: SARS-CoV-2 infected patients with pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002541-22 Sponsor Protocol Number: EFC14092 Start Date*: 2015-04-02
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-001745-40 Sponsor Protocol Number: COVID-SARI-001 Start Date*: 2020-04-23
    Sponsor Name:ASST FATEBENEFRATELLI SACCO
    Full Title: PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION
    Medical condition: Patients with COVID-19 infection
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004862 10048847 Lung infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-003538-16 Sponsor Protocol Number: EFC10832 Start Date*: 2013-02-04
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inade...
    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: LT (Completed) CZ (Completed) HU (Completed) ES (Completed) DE (Completed) PT (Completed) GR (Completed) AT (Completed) IT (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004000-35 Sponsor Protocol Number: DRI13926 Start Date*: 2017-02-24
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenil...
    Medical condition: Juvenile Idiopathic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10059176 Juvenile idiopathic arthritis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) EE (Prematurely Ended) FI (Trial now transitioned) CZ (Completed) PL (Completed) NL (Ongoing) Outside EU/EEA BG (Trial now transitioned) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001255-40 Sponsor Protocol Number: STRIKE-SARS-CoV2 Start Date*: 2020-04-16
    Sponsor Name:Clínica Universidad de Navarra/Universidad de Navarra
    Full Title: Sarilumab Treatment In cytoKinE storm caused by infection with COVID-19.
    Medical condition: Severe pneumonia caused by infection with SARS CoV 2.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-016266-90 Sponsor Protocol Number: EFC11072 Start Date*: 2011-05-03
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seg...
    Medical condition: Artritis Reumatoide _____________________________________ Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) HU (Completed) EE (Completed) DE (Completed) LT (Completed) PT (Completed) NL (Completed) GR (Completed) RO (Completed) AT (Completed) BE (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: 2020-001290-74 Sponsor Protocol Number: SARICOVID Start Date*: 2020-04-11
    Sponsor Name:Consorci Parc de Salut Mar (PSMAR)
    Full Title: Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care
    Medical condition: Patients with confirmed COVID-19 infection and criteria for mild-moderate pneumonia (CURB-65 ≤1 i SatO2 ≥90%, MEWS score less than 3) and IL6 values of 20 pg / ml, will be randomly assigned to a sa...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
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