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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT03104374

Run by

AbbVie

People needed

642

Starts

2017-05-01

Expected to finish

2024-09-30

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
• Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
• Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
• Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

You may not qualify if…

• Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
• Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
• History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Where it is running

• Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047 — Mesa, Arizona, United States
• Sun Valley Arthritis Center Ltd. /ID# 161203 — Peoria, Arizona, United States
• Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006 — Phoenix, Arizona, United States
• Osteoporosis Medical Center /ID# 161411 — Beverly Hills, California, United States
• Covina Arthritis Clinic /ID# 159919 — Covina, California, United States
• Triwest Research Associates /ID# 159915 — El Cajon, California, United States
• Duplicate_Providence Medical Foundation /ID# 160005 — Fullerton, California, United States
• C.V. Mehta MD, Med Corporation /ID# 161192 — Hemet, California, United States
• Care Access Research, Huntington Beach /ID# 160049 — Huntington Beach, California, United States
• Purushotham & Akther Kotha MD, Inc /ID# 159834 — La Mesa, California, United States
• Stanford University School of Med /ID# 161402 — Stanford, California, United States
• Inland Rheum Clin Trials Inc. /ID# 159839 — Upland, California, United States
• Medvin Clinical Research /ID# 160045 — Whittier, California, United States
• Denver Arthritis Clinic /ID# 159899 — Denver, Colorado, United States
• Colorado Arthritis Associates /ID# 159856 — Lakewood, Colorado, United States
• Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409 — Aventura, Florida, United States
• International Medical Research /ID# 160051 — Daytona Beach, Florida, United States
• Precision Research Organization /ID# 161293 — Miami Lakes, Florida, United States
• Duplicate_Suncoast Clinical Research /ID# 161417 — New Port Richey, Florida, United States
• Millennium Research /ID# 159833 — Ormond Beach, Florida, United States
• Arthritis Center, Inc. /ID# 163463 — Palm Harbor, Florida, United States
• Gulf Region Clinical Res Inst /ID# 159860 — Pensacola, Florida, United States
• Sarasota Arthritis Center /ID# 159854 — Sarasota, Florida, United States
• BayCare Medical Group /ID# 161405 — St. Petersburg, Florida, United States
• Alabama Medical Group, PC /ID# 159836 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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