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A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

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Trial Profile

A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2022

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At a glance

  • Drugs Tocilizumab (Primary) ; Methotrexate; Methotrexate
  • Indications Joint disorders; Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms LITHE
  • Sponsors Roche

    • Most Recent Events

    • 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
    • 06 Jun 2020 Results of pooled analysis from seven studies (OPTION, RADIATE, TOWARD, LITHE, ACT-RAY, ADACTA and BREVACTA) presented at the 21st Annual Congress of the European League Against Rheumatism.
    • 06 Jun 2020 Results of pooled analysis from three phase III studies (OPTION, TOWARD and LITHE) presented at the 21st Annual Congress of the European League Against Rheumatism
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