A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis

Trial Profile

A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Sep 2017

At a glance

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

    • 22 Sep 2017 According to a Janssen Biotech media release, the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA.
    • 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).
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