CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,705 enrolled
Drug / intervention
Adalimumab +3 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/NCT03104400
NCT03104400Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

AbbVie·interventional·Posted Apr 7, 2017·Updated Sep 22, 2025

In Brief

A Phase 3 clinical trial evaluating Adalimumab, Upadacitinib, and 2 other interventions for Psoriatic Arthritis. Completed, enrolled 1,705 participants across 345 sites in 46 countries.

Detailed Summary

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesArgentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 7, 2017
Enrollment StartApr 27, 2017
Primary CompletionSep 26, 2019
Study CompletionSep 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.2 years ago

Interventions

Adalimumabdrug

Administered by subcutaneous injection

Upadacitinibdrug

Oral tablet

Placebo to Upadacitinibdrug

Oral tablet

Placebo to Adalimumabdrug

Administered by subcutaneous injection