CompletedPhase 3

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

United States1,705 participantsStarted 2017-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. \>= 1 erosion on x-ray as determined by central imaging review or;
✓. high-sensitivity C-reactive protein (hs-CRP) \> laboratory defined upper limit of normal (ULN).
✓. \>= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
✓. \>= 4 weeks for all others.

What they're measuring

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT03104400

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-26

Results submitted2021-12-27

View on ClinicalTrials.gov More Psoriatic Arthritis trials