Upadacitinib for Psoriatic Arthritis
(UP-SPOUT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byWalter Maksymowych, Dr.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: CARE ARTHRITIS LTD.
Must not be taking: JAK-inhibitors, TYK2-inhibitors
Disqualifiers: Active infection, Tuberculosis, Hepatitis, HIV, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of certain medications like NSAIDs, mild opioids, oral corticosteroids, topical therapies, and some csDMARDs for a specified period before starting the study. If you are on bioDMARD therapy, a washout period (time without taking the medication) is required before the screening MRI, but you should not stop a successful biological therapy just to join the study.
What data supports the effectiveness of the drug Upadacitinib for treating psoriatic arthritis?
Research shows that Upadacitinib helps improve symptoms and quality of life for people with psoriatic arthritis, especially those who haven't responded well to other treatments. Studies found it reduces pain and improves patient-reported outcomes compared to a placebo or other drugs like adalimumab.
12345Is upadacitinib safe for humans?
Upadacitinib has been studied for safety in conditions like rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis, with data showing it is generally safe for long-term use, though some adverse events have been reported. It is important to discuss potential risks with a healthcare provider.
16789How is the drug Upadacitinib different from other treatments for psoriatic arthritis?
Upadacitinib is unique because it is an oral Janus kinase inhibitor, which works by blocking specific enzymes involved in the inflammatory process, and is effective for patients who have not responded well to biologic treatments. This makes it a novel option for those with psoriatic arthritis who have had inadequate responses to other therapies.
110111213Eligibility Criteria
Adults with active psoriatic arthritis, evidence of axial involvement, and chronic back pain may join. They must have tried NSAIDs without success or cannot take them due to intolerance. Participants need a history or current signs of psoriasis, no rheumatoid factor, possible nail changes or dactylitis, and radiologic signs of bone formation near joints.Inclusion Criteria
Evidence of axial involvement demonstrated by previous imaging techniques
I am 18 years old or older.
I understand and agree to follow the study rules and will sign the consent form.
+10 more
Exclusion Criteria
History of certain autoimmune diseases or inflammatory conditions
I do not have any current infections needing treatment.
I have or might have COVID-19.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Upadacitinib or placebo tablets once per day
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The UP-SPOUT trial is testing Upadacitinib (Rinvoq), comparing it against a placebo in people with active psoriatic arthritis to see its effects on spondyloarthritis outcomes. It's randomized and controlled; participants won't know if they're getting the real drug or a dummy pill.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: UpadacitinibExperimental Treatment1 Intervention
Participants randomized to this arm will receive Upadacitinib 15 mg tablets, once per day, for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive matching placebo tablets with no active ingredients, once per day, for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
DM Clinical ResearchTomball, TX
The Ottawa Hospital Research InstituteOttawa, Canada
Groupe de Recherche en Maladies Osseuses (G.R.M.O.) Inc.Québec, Canada
Loading ...
Who Is Running the Clinical Trial?
CARE ARTHRITIS LTD.Lead Sponsor
References
Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice. [2023]Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study.
Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. [2022]The aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1.
Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: post hoc analysis of three randomised clinical trials. [2022]Evaluate the effect of upadacitinib on pain outcomes in patients with active psoriatic arthritis (PsA) or ankylosing spondylitis (AS) across 3 randomised trials (SELECT-PsA 1 and 2 for PsA; SELECT-AXIS 1 for AS).
Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. [2022]Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR).
Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. [2023]To assess the long-term safety and efficacy of upadacitinib in patients with psoriatic arthritis (PsA) and an inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs) who completed up to 152 weeks of treatment in the SELECT-PsA 2 study (ClinicalTrials.gov: NCT03104374).
Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis of the FDA Adverse Event Reporting system. [2023]Upadacitinib was approved to treat rheumatoid arthritis, psoriasis, ulcerative colitis, ankylosing spondylitis, and atopic dermatitis. This study assessed the adverse events (AEs) associated with upadacitinib by mining data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. [2023]To evaluate the long-term safety profile for upadacitinib across rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and atopic dermatitis (AD).
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. [2022]This integrated analysis describes the safety profile of upadacitinib, an oral Janus kinase inhibitor, at 15 and 30 mg once daily for up to 3 years of exposure in patients with active psoriatic arthritis (PsA) who had a prior inadequate response or intolerance to ≥ 1 non-biologic or biologic disease-modifying antirheumatic drug.
Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. [2023]The objective of this post-hoc analysis was to assess the efficacy and safety of upadacitinib in psoriatic arthritis (PsA) patients with axial involvement.
Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. [2021]The Janus kinase inhibitor upadacitinib is a potential treatment for psoriatic arthritis. The efficacy and safety of upadacitinib as compared with adalimumab, a tumor necrosis factor α inhibitor, in patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs are unclear.
Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. [2021]Upadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy.
Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. [2022]Upadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD).
Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. [2022]Upadacitinib is an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA) and recently approved by the European Medicines Agency for the treatment of psoriatic arthritis (PsA). The efficacy and safety profile of upadacitinib in PsA have been established in the SELECT-PsA program in two global phase III studies, which evaluated upadacitinib 15 and 30 mg q.d. The analyses described here characterized upadacitinib pharmacokinetics and exposure-response relationships for efficacy and safety endpoints using data from the SELECT-PsA studies. Upadacitinib pharmacokinetics in patients with PsA were characterized through a Bayesian population analysis approach and were comparable to pharmacokinetics in patients with RA. Exposure-response relationships for key efficacy and safety endpoints were characterized using data from 1916 patients with PsA. The percentage of patients achieving efficacy endpoints at week 12 (American College of Rheumatology [ACR]50 and ACR70), 16 and 24 (sIGA0/1) increased with increasing upadacitinib average plasma concentration over a dosing interval, whereas no clear exposure-response trend was observed for ACR20 at week 12 or ACR20/50/70 at week 24 within the range of plasma exposures evaluated in the phase III PsA studies. No clear trends for exposure-response relationships were identified for experiencing pneumonia, herpes zoster infection, hemoglobin less than 8 g/dl, lymphopenia (grade ≥ 3), or neutropenia (grade ≥ 3) after 24 weeks of treatment. Shallow relationships with plasma exposures were observed for serious infections and hemoglobin decrease greater than 2 g/dl from baseline at week 24. Based on exposure-response analyses, the upadacitinib 15 mg q.d. regimen is predicted to achieve robust efficacy in patients with PsA and to be associated with limited incidences of reductions in hemoglobin or occurrence of serious infections.