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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 Intolerant of TNF Antagonists

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Trial Profile

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 Intolerant of TNF Antagonists

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2022

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At a glance

  • Drugs Sarilumab (Primary) ; Hydroxychloroquine; Leflunomide; Methotrexate; Sulfasalazine; Tocilizumab
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Registrational
  • Acronyms ASCERTAIN; SARIL-RA-ASCERTAIN
  • Sponsors Sanofi

Most Recent Events

  • 01 May 2022 Results of a pharmacogenomic study (n=1075) assessing genetic variation in UGT1A1 using data from three clinical studies: MOBILITY, TARGET, and ASCERTAIN published in the Pharmacogenomics Journal
  • 26 May 2020 Results of Population Pharmacokinetic-Pharmacodynamic Relationships of Sarilumab from four phase I-III studies (NCT01011959, NCT01061736, NCT01709578, NCT01768572 ) published in the Clinical Pharmacokinetics
  • 15 Jul 2019 Results (n=2887) of post-hoc pooled analysis of eight studies (MOBILITY, NCT01061736; TARGET, NCT01709578; ASCERTAIN, NCT01768572; MONARCH, NCT02332590; ACT11575, NCT01217814; ONE, NCT02121210; COMPARE, NCT01764997; and EASY, NCT02057250) and one open label extension (EXTEND; NCT01146652) assessing long-term safety up to 7 years follow up of sarilumab in rheumatoid arthritis patients, published in the Rheumatology.

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