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A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe active rheumatoid arthritis

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Trial Profile

A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe active rheumatoid arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2022

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At a glance

  • Drugs Tocilizumab (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms AMBITION; AMBITION-LTE
  • Sponsors Roche
  • Most Recent Events

    • 02 Sep 2021 Planned number of patients changed from 500 to 650.
    • 26 Aug 2020 Results of a pooled analysis from twelve phase 3 and 4 clinical trials: ACT-RAY, ACT-STAR, ACT-SURE, ADACTA, AMBITION, BREVACTA, COMP-ACT, LITHE, OPTION, ROSE, SUMMACTA and TOWARD assessing predictors of response, including demographics, disease characteristics at baseline published in the Rheumatology
    • 07 Feb 2020 Results (n=1750) of post hoc analysis determining if inclusion of patients on background GC use influences efficacy and safety outcomes of RA randomised clinical trials from AMBITION, ACT-RAY, ADACTA and FUNCTION on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy. published in the Annals of the Rheumatic Diseases
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