A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 30 Nov 2017
At a glance
- Drugs Tofacitinib (Primary)
- Indications Psoriatic arthritis
- Focus Adverse reactions; Registrational
- Acronyms OPAL BALANCE
- Sponsors Pfizer
- 03 Aug 2017 According to a Pfizer media release, the Arthritis Advisory Committee (AAC) of the US FDA has voted 10 to 1 to recommend approval of the supplemental New Drug Application for tofacitinib (XELJANZ) 5 mg twice daily and XELJANZ XR extended release 11 mg once daily (QD).
- 26 Jul 2017 Status changed from recruiting to active, no longer recruiting.
- 17 Jun 2017 Results (n=680) assessing safety and efficacy presented at the 18th Annual Congress of the European League Against Rheumatism.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History