Upadacitinib vs. Adalimumab for Psoriatic Arthritis
(SELECT - PsA 1 Trial)

Recruiting in Palo Alto (17 mi)

+346 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

AbbVie Inc.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people with active psoriatic arthritis who haven't responded well to treatments like methotrexate or sulfasalazine. They should have at least 3 tender and swollen joints, a history of plaque psoriasis, and higher than normal levels of inflammation markers. Those with other types of inflammatory joint diseases or previous JAK inhibitor use can't participate.

Inclusion Criteria

I am on 2 or fewer non-biologic DMARDs for at least 12 weeks and at a stable dose for 4 weeks.

I have at least 3 tender and 3 swollen joints.

I have been diagnosed with Psoriatic Arthritis for at least 6 months.

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Exclusion Criteria

You can still participate if your previous diagnosis of reactive arthritis or certain types of spondyloarthritis changes to psoriatic arthritis (PsA).

I am currently taking more than two non-biologic DMARDs or using specific DMARDs not listed.

I was diagnosed with fibromyalgia, but now have a confirmed diagnosis of PsA.

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Treatment Details

Interventions

Adalimumab (Tumor Necrosis Factor (TNF) Inhibitor)
Placebo (Drug)
Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe study tests two doses of Upadacitinib against a placebo and Adalimumab in those with moderate to severe psoriatic arthritis unresponsive to non-biologic DMARDs. It aims to assess effectiveness in symptom relief and preventing joint damage over time.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Upadacitinib 30 mgExperimental Treatment2 Interventions

Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Group II: Upadacitinib 15 mgExperimental Treatment2 Interventions

Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Group III: AdalimumabActive Control2 Interventions

Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks. Period 2: Participants continue to receive adalimumab 40 mg every other week.

Group IV: Placebo / Upadacitinib 15 mgPlacebo Group3 Interventions

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Group V: Placebo / Upadacitinib 30 mgPlacebo Group3 Interventions

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Adalimumab is already approved in Canada, Japan for the following indications: