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U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naive Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

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Trial Profile

U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naive Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2022

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At a glance

  • Drugs Tocilizumab (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms U-ACT-EARLY
  • Sponsors Roche

Most Recent Events

  • 14 Nov 2022 Results (n=96) assessing to validate urotensin-2 mRNA expression as a marker for tocilizumab in early rheumatoid arthritis, presented at the ACR Convergence 2022.
  • 05 Jun 2021 Results from NCT01034137 (n=95) and from other study analysing potential baseline gene expression markers for Tocilizumab response in early RA patients using an RNA-sequencing approach, presented at the 22nd Annual Congress of the European League Against Rheumatism
  • 15 Jun 2019 Results identifying relevant metabolites and important metabolomic pathways associated with achieving sustained drug-free remission (sDFR) after a treat to target tocilizumab or methotrexate based strategy initiated in DMARD naive early RA patients presented at the 20th Annual Congress of the European League Against Rheumatism

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