A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
Phase of Trial: Phase III
Latest Information Update: 31 Jul 2017
At a glance
- Drugs Tofacitinib (Primary)
- Indications Ulcerative colitis
- Focus Adverse reactions
- Acronyms OCTAVE; OCTAVE Open
- Sponsors Pfizer
- 13 Jul 2017 According to a Pfizer media release, the supplemental New Drug Application (sNDA) for XELJANZ for adult patients with moderately to severely active ulcerative colitis (UC), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA. Data from OCTAVE Induction 1, OCTAVE Induction 2, OCTAVE Sustain and OCTAVE Open studies supported the application.
- 15 Jul 2016 Planned primary completion date changed from 1 May 2016 to 1 Jul 2018.
- 02 Nov 2015 Planned number of patients changed from 725 to 900, according to ClinicalTrials.gov record.