At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
Tofacitinib +5 moredrug
Likely dose
Tofacitinib 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
In Brief
A Phase 3 clinical trial evaluating Tofacitinib and Placebo for Psoriatic Arthritis. Completed, enrolled 395 participants across 125 sites in 14 countries.
Detailed Summary
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesAustralia, Belgium, Brazil, Czechia, France, Germany, Mexico, Poland, Russia, Slovakia, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartAug 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedJun 20, 2013
Enrollment StartAug 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.0 years ago
Interventions
Tofacitinibdrug
tablets, 5 mg BID x 6 months
Tofacitinibdrug
tablets, 10 mg BID x 6 months
Placeboother
tablets, to match tofacitinib 5 mg BID x 3 months
Tofacitinibdrug
tablets, 5 mg BID x 3 months
Placeboother
tablets, to match tofacitinib 10 mg BID x 3 months
Tofacitinibdrug
tablets, 10 mg BID x 3 months