Actively Recruiting
A Randomized, Placebo-controlled, Multicenter 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
4 weeks
Total Duration
On this page
Sponsors
C
CARE ARTHRITIS LTD.
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Upadacitinib on spondyloarthritis outcomes in adults with active psoriatic arthritis. This randomized, placebo-controlled, multicenter study aims to understand how this treatment impacts inflammation and disease activity in patients who have shown inadequate response or intolerance to other treatments. The trial is sponsored by CARE ARTHRITIS LTD. and is in Phase 4. Participants will be randomly assigned to receive either Upadacitinib 15 mg tablets once daily or matching placebo tablets once daily, each for a duration of 12 weeks. The study compares these two groups to assess changes in MRI inflammation scores and disease activity measures. The trial uses quadruple masking to ensure unbiased results. During the study, participants will undergo assessments including MRI scans of the sacroiliac joints and spine, evaluations of disease activity scores such as the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) and BASDAI, and monitoring of adverse events up to 28 weeks. Stable use of certain medications is required before baseline. The total participation duration spans from screening through the 12-week treatment period with follow-up for safety monitoring.
CONDITIONS
Brief 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 and willing to follow protocol requirements and provide informed consent
- Diagnosed with psoriatic arthritis by a rheumatologist
- Meet CASPAR classification criteria for psoriatic arthritis with inflammatory articular disease and specific points in psoriasis, nail dystrophy, rheumatoid factor, dactylitis, or radiologic evidence
- Evidence of axial involvement confirmed by previous imaging and central reader assessment
- MRI shows definite active inflammation in sacroiliac joints and/or spine
- Chronic back pain present in the 3 months before screening
- Active disease with BASDAI and TBP scores of 4 or higher at screening and baseline
- Inadequate response or intolerance to at least two NSAIDs over 4 weeks
- For females of childbearing potential: negative pregnancy tests and use of effective birth control methods from study start through 30 days after last dose
- Stable use of NSAIDs, analgesics, corticosteroids, topical therapies, and certain csDMARDs prior to baseline as specified
- Prior treatment with DMARD therapy for at least 3 months and/or NSAID therapy for 4 weeks but with continued active disease or intolerance
- Appropriate washout period from bioDMARD therapy if currently used
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 recurrent or disseminated herpes zoster or herpes simplex
- Immunodeficiency or clinical signs of tuberculosis
- Positive tuberculosis tests without appropriate prophylactic treatment
- Chronic hepatitis B or C, or HIV infection
- Pregnant, breastfeeding, or planning pregnancy within 4 weeks after last dose
- Other chronic inflammatory or autoimmune diseases excluding certain conditions
- Use of strong CYP3A inhibitors or inducers
- Prior treatment with upadacitinib or other JAK/TYK2 inhibitors
- Hypersensitivity to upadacitinib components
- Recent steroid treatments above specified doses
- Participation in another investigational drug study recently
- History of infected joint prosthesis
- Recent or history of certain malignancies
- Conditions affecting oral drug absorption
- Recent significant trauma or surgery
- Severe uncontrolled organ disorders
- History of cardiovascular events or thrombosis
- Recent live vaccinations
- Specified abnormal lab values
- Contraindications to MRI including claustrophobia or metal implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either Upadacitinib 15 mg tablets or matching placebo tablets once per day as part of the trial treatment.
Visits occur periodically during treatment for medication administration and assessments
Duration - Up to 16 weeks after treatment
Participants are monitored for safety and adverse events after treatment ends.
Approximately 4 visits for safety monitoring
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
R
Rana Dadashova
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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