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A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).

Trial Profile

A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Acronyms ROSE
  • 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
    • 26 Oct 2011 Status changed from active, no longer recruiting to completed, as reported in Annals of the Rheumatic Diseases.
    • 26 Sep 2011 Primary endpoint 'American-College-of-Rheumatology-50%-response-criteria' has been met according to results published in the Annals of the Rheumatic Diseases.
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