A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine
Phase of Trial: Phase III
Latest Information Update: 02 Aug 2017
At a glance
- Drugs Sirukumab (Primary)
- Indications Rheumatoid arthritis
- Focus Adverse reactions; Registrational
- Acronyms SIRROUND-M
- Sponsors Janssen Pharmaceutical KK
- 02 Aug 2017 According to a Janssen Biotech media release, the efficacy and safety data from a global Phase 3 clinical development program inclusive of five studies (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M, SIRROUND-LTE) was reviewed by the Arthritis Advisory Committee of the FDA.
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History