A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs Sirukumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms SIRROUND-T
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 02 Aug 2017 According to a Janssen Biotech media release, the Arthritis Advisory Committee of the US FDA did not recommend the approval of sirukumab (proposed trade name PLIVENSIA) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Final approval from the FDA is still pending.
    • 02 Aug 2017 According to a Janssen Biotech media release, the US FDA did not recommend the approval of sirukumab (proposed trade name PLIVENSIA) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
    • 17 Jun 2017 Results assessing incidence of neutropenia from completed and ongoing SIRROUND clinical studies, presented at the 18th Annual Congress of the European League Against Rheumatism.
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