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: 22 Sep 2017
At a glance
- Drugs Sirukumab (Primary)
- Indications Rheumatoid arthritis
- Focus Adverse reactions; Registrational
- Acronyms SIRROUND-M
- Sponsors Janssen Pharmaceutical KK
- 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 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History