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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

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

    • 08 Nov 2017 Results of two phase III trials (NCT00106522 and NCT00106535) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 10 Jun 2017 Biomarkers information updated
    • 08 Jun 2017 Results assessing liver safety with long-term tocilizumab treatment for rheumatoid arthritis using pooled data (n= 4171) from five core phase 3 placebo-controlled studies (OPTION, TOWARD, LITHE, AMBITION, RADIATE), a clinical pharmacology study (NCT00365001), a phase 4 study (ADACTA) or long-term extension studies, published in the Arthritis and Rheumatology Journal.
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