Study of Upadacitinib for Psoriatic Arthritis
This study, called UP-SPOUT, is looking at how a medication called Upadacitinib (Rinvoq) affects people with active psoriatic arthritis (a type of arthritis linked to psoriasis) and spondyloarthritis (a type of arthritis that affects the spine). We want to see if Upadacitinib can reduce inflammation in the joints of the spine and pelvis. You might be able to join if you are 18 or older and have psoriatic arthritis. Participants will receive either Upadacitinib or a placebo (an inactive pill). The main goal is to measure changes in inflammation using MRI scans after 12 weeks. The study is currently unclear on its recruitment status and plans to enroll 100 people.
- Study design
- This is a randomized, placebo-controlled study, meaning participants will be randomly assigned to receive either Upadacitinib or a placebo. It aims to enroll 100 participants.
- What's involved
- Participants will take a 15mg tablet once per day. The primary measurement for the study is taken at 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 12 weeks, but the overall follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06454188
A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis
Recruiting
PHASE4Ages 18+InterventionalTreatmentCARE ARTHRITIS LTD.
~100 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Upadacitinib 15 MG [Rinvoq]Placebo
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup
Measured over 12 weeks
Conditions
Where it's being run
5 sites across 5 statesOhio1
Oregon1
Pennsylvania1
Ontario1
Quebec1
Study leadership
- Walter Maksymowych, Dr. · PRINCIPAL_INVESTIGATOR · CARE ARTHRITIS LTD.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Combined (estrogen- and progestogen-containing) hormonal birth control (oral, intravaginal, transdermal, injectable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
Progestogen-only hormonal birth control (oral, injectable, implantable) associated with inhibition of ovulation initiated at least 30 days prior to study baseline.
Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a hysterosalpingogram confirms success of the procedure) (For Japan: only bilateral tubal ligation).
Intrauterine device (IUD).
Intrauterine hormone-releasing system (IUS).
Vasectomized sexual partner (the partner has received medical confirmation of the surgical success of the vasectomy and is the sole sexual partner of the trial subject).
Practice true abstinence (unless not acceptable per local practices), defined as: refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable). 11. If required per local practices, females of childbearing potential must commit to using 2 methods of contraception (either 2 highly effective methods or 1 highly effective method combined with 1 effective method). Effective methods of birth control are the following:
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, initiated at least 30 days prior to baseline.
Male or female condom with or without spermicide.
Cap, diaphragm, or sponge with spermicide.
A combination of male condom with a cap, diaphragm, or sponge with spermicide (double barrier method).
In questionable cases of menopausal status, a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 pg/ml is confirmatory. 12. Subjects who are regularly taking NSAIDs or analgesics (including mild opioids) as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days prior to the baseline visit. If entering the study on concomitant tramadol, combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone, and/or non-opioid analgesics, subject must be on stable dose(s) for at least 14 days prior to the baseline Visit. However, subject must not have used opioid analgesics (except for combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone which are allowed) within 14 days prior to the BL Visit. 13. Subjects taking oral corticosteroids must be on an average daily and stable dose of ≤10mg/day prednisone or equivalent for at least 14 days prior to the baseline visit. 14. Subjects taking topical therapies (e.g., topical JAKi, salicylic acid preparations, corticosteroids, retinoids) are allowed, but must be on a stable dose at least 4 weeks prior to the BL visit. 15. Subjects entering the study on the following concomitant csDMARDs must be on a stable dose as indicated below for at least 28 days prior to the baseline Visit (in case of Leflunomide washout must be either 8 weeks or 4 weeks with a standard cholestyramine wash-out). A combination of up to 2 background csDMARDs is allowed EXCEPT the combination of methotrexate (MTX) and leflunomide.
MTX (≤ 25 mg/week); or
Sulfasalazine (SSZ) (≤ 3 g/day); or
Hydroxychloroquine (≤ 400 mg/day); or
Chloroquine (≤ 250 mg/day); or
Leflunomide (≤ 20 mg/day); or
Apremilast (≤ 60 mg/day) 16. Subjects must have been treated for ≥ 3 consecutive months prior to the study entry with DMARD therapy (including csDMARD and/or bDMARD) and/or for ≥4 weeks of NSAID therapy (if csDMARDs are not indicated for their axial disease, in accordance with local product label for PSA, or nr-axSpA/AS for the subset with purely axial disease), but continue to exhibit active SpA, or had to discontinue previous DMARD and/or NSAID treatment due to intolerability or toxicity, irrespective of treatment duration .
Exclusion
Boceprevir
Cobicistat
Clarithromycin
Conivaptan
Grapefruit (fruit or juice)
Indinavir
Itraconazole
Ketoconazole
Lopinavir/Ritonavir
Mibefradil
Nefazodone
Nelfinavir
Posaconazole
Ritonavir
Saquinavir
Telaprevir
Telithromycin
Troleandomycin
Voriconazole
Carbamazepine
Phenytoin
Rifampin
Rifapentine
St. John's Wort
Examples of live vaccines include, but are not limited to, the following:
Administration of inactivated (non-replicating) vaccines is permitted prior to or during the study according to local practice guidelines. Examples of common vaccines that are inactivated, toxoid or biosynthetic include, but are not limited to, injectable influenza vaccine, pneumococcal, Shingrix (zoster vaccine, recombinant, adjuvanted), pertussis (Tdap) vaccines, monkey pox vaccine and SARS-CoV-2 (inactivated, mRNA, RNA). Whenever possible, subjects should not have received a COVID-19 vaccination in the 7 days prior to randomization or plan to receive a COVID-19 vaccination within the first 7 days after initiation of study drug. 25. Any of the following lab abnormalities detected at screening:
What this trial measures
- Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup12 weeks