Clinical trial · Observational
A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis
Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriatic Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Ustekinumab Treatment
- description
- Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.
- interventionNames
- Drug: No Intervention
- label
- Cohort 2: TNFi Treatment
- description
- Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.
- interventionNames
- Drug: No Intervention
Primary outcomes (22)
- measure
- Time to Drug Stop or Switch
- timeFrame
- Up to Month 36
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria * Must be starting either STELARA or any new approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilar) as a new biologic disease-modifying antirheumatic drug (bDMARD) therapy in a first, second or third line of bDMARD therapy for PsA at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit * Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Exclusion Criteria: * Participant is starting STELARA or a TNFi therapy as fourth or further line of biologic treatment * Participant is unwilling or unable to participate in long-term data collection * Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point * Participant is currently enrolled in an interventional study
References
Publications (5)
- DERIVEDAlle G, Lopez-Medina C, Siebert S, Lavie F, Noel W, Smolen JS, Gossec L. Patient Profiles in Randomized Controlled Trials Versus a Real-World Study in Psoriatic Arthritis: Scoping Review and Metaanalysis. J Rheumatol. 2025 Feb 1;52(2):138-144. doi: 10.3899/jrheum.2024-0653. PMID 39547694
- DERIVEDGossec L, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibanez B, Korotaeva TV, Lavie F, Noel W, Nurmohamed MT, Sfikakis PP, Sharaf M, Theander E, Smolen JS. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: results from the PsABio real-world study. Arthritis Res Ther. 2023 Jun 23;25(1):109. doi: 10.1186/s13075-023-03058-y. PMID 37353788
- DERIVEDVan Kuijk AWR, Nurmohamed MT, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibanez B, Korotaeva TV, Lavie F, Sharaf M, Noel W, Theander E, Smolen JS, Gossec L, van der Horst-Bruinsma IE. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: real-world data. Rheumatology (Oxford). 2023 Oct 3;62(10):3382-3390. doi: 10.1093/rheumatology/kead089. PMID 36810788
- DERIVEDGossec L, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibanez B, Korotaeva TV, Lavie F, Noel W, Nurmohamed MT, Sfikakis PP, Sharaf M, Theander E, Smolen JS. Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: final 3-year results from the PsABio real-world study. Ann Rheum Dis. 2023 Apr;82(4):496-506. doi: 10.1136/ard-2022-222879. Epub 2022 Dec 13. PMID 36600178
- DERIVEDGossec L, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibanez B, Korotaeva TV, Lavie F, Noel W, Nurmohamed MT, Sfikakis PP, Theander E, Smolen JS. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 Jun;81(6):823-830. doi: 10.1136/annrheumdis-2021-221640. Epub 2022 Feb 24.