CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 642 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.

Search/NCT03104374
NCT03104374Phase 3Completed

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

AbbVie·interventional·Posted Apr 7, 2017·Updated Sep 11, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo and Upadacitinib for Psoriatic Arthritis. Completed, enrolled 642 participants across 165 sites in 19 countries.

Detailed Summary

This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Canada, Chile, Czechia, France, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 7, 2017
Enrollment StartMay 1, 2017
Primary CompletionJul 23, 2019
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.2 years ago

Interventions

Placebodrug

Oral tablet

Upadacitinibdrug

Oral tablet