A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) — SELECT - PsA 2  

Psoriatic Arthritis Clinical Trial

Official title: 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) - SELECT - PsA 2

Status Active, not recruiting

Clinical Trial Summary

The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD).

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.

Clinical Trial Description

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 3 years (Period 2), and a 30-day follow-up call or visit.

Period 1 includes 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of blinded treatment where all participants were to receive upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:

• Group 1: Upadacitinib 15 mg

• Group 2: Upadacitinib 30 mg

• Group 3: Placebo for 24 weeks followed by upadacitinib 15 mg

• Group 4: Placebo for 24 weeks followed by upadacitinib 30 mg

Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2, and continue study treatment as assigned in Period 1 in a blinded manner until the last participant completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and study drug will be dispensed in an open-label fashion until the completion of Period 2.

At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and/or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatic Diseases

• NCT number: NCT03104374
• Study type: Interventional
• Source: AbbVie
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 1, 2017
• Completion date: September 30, 2024