Actively Recruiting
A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis
Led by CARE ARTHRITIS LTD. · Updated on 2026-04-03
100
Participants Needed
5
Research Sites
199 weeks
Total Duration
On this page
Sponsors
C
CARE ARTHRITIS LTD.
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)
CONDITIONS
Official Title
A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Able to understand, willing to follow protocol, and provide informed consent
- Diagnosed with psoriatic arthritis by a rheumatologist
- Meet CASPAR criteria with inflammatory joint, spine, or entheseal disease and at least 3 points from psoriasis, nail dystrophy, negative rheumatoid factor, dactylitis, or radiologic evidence
- Evidence of axial involvement confirmed by imaging and positive MRI inflammation of sacroiliac joints or spine
- Chronic back pain within 3 months before screening
- Active disease with BASDAI and TBP scores of 4 or higher at screening and baseline
- History of inadequate response or intolerance to at least two NSAIDs over 4 weeks
- Female participants of childbearing potential must have negative pregnancy tests and use at least one effective birth control method from study start through 30 days after last dose
- Stable doses of NSAIDs, analgesics, corticosteroids (≤10 mg prednisone or equivalent), topical therapies, and certain csDMARDs for specified durations prior to baseline
- Previous treatment with DMARDs and/or NSAIDs but continuing active disease or intolerant to prior treatments
- Prior biologic DMARD washout periods observed as required before screening MRI
You will not qualify if you...
- Active infections requiring recent treatment or chronic recurring infections
- Recent or suspected COVID-19 infection without recovery
- History of multiple or severe herpes zoster or herpes simplex infections
- Immunodeficiency or current tuberculosis infection or positive tuberculosis tests without prophylactic treatment
- Chronic hepatitis B or C infection or HIV infection
- Pregnant, breastfeeding, or planning pregnancy during study or within 4 weeks after last dose
- Other chronic inflammatory or systemic autoimmune diseases except stable Crohn's disease or ulcerative colitis
- Use of strong CYP3A inducers or inhibitors
- Prior treatment with upadacitinib or other JAK/TYK2 inhibitors
- Known hypersensitivity to upadacitinib components
- Recent steroid use above allowed doses or recent investigational drug use
- History of infected joint prosthesis with prosthesis still in place
- Recent or active malignancies except certain treated skin or cervical cancers
- Conditions affecting oral drug absorption
- Recent significant trauma, surgery, or planned elective surgery during study
- Severe uncontrolled organ disorders
- History of cardiovascular events or thrombosis
- Recent live vaccinations or plans for live vaccination during study
- Certain lab abnormalities at screening
- Contraindications for MRI including claustrophobia, implanted devices, or metal foreign bodies except MRI-safe implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9
Actively Recruiting
5
Groupe de Recherche en Maladies Osseuses (G.R.M.O.) Inc.
Québec, Quebec, Canada, G1V 3M7
Actively Recruiting
Research Team
A
Amanda Carapellucci
CONTACT
R
Rana Dadashova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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