A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 11 Dec 2017
At a glance
- Drugs Sirukumab (Primary)
- Indications Rheumatoid arthritis
- Focus Adverse reactions; Registrational
- Acronyms SIRROUND-LTE
- Sponsors Janssen Research & Development
- 28 Nov 2017 Planned primary completion date changed from 25 Nov 2019 to 30 Apr 2018.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History