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An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

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Trial Profile

An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2019

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At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms SARIL-RA-ONE
  • Sponsors Sanofi

Most Recent Events

  • 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.
  • 15 Jun 2019 Results assessing long-term safety from the sarilumab clinical development program from MOBILITY (NCT01061736), TARGET (NCT01709578), ASCERTAIN (NCT01768572), EASY (NCT02057250), COMPARE (NCT01764997), ACT11575 (NCT01217814), MONARCH (NCT02332590), ONE (NCT02121210), and the open-label extension EXTEND (NCT01146652) trials presented at the 20th Annual Congress of the European League Against Rheumatism
  • 24 Oct 2018 Results presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting

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