A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis
NCT ID: NCT02627768
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
991 participants
OBSERVATIONAL
2015-12-17
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Ustekinumab Treatment
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.
No Intervention
Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab or a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy will be observed.
Cohort 2: TNFi Treatment
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.
No Intervention
Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab or a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy will be observed.
Interventions
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No Intervention
Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab or a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy will be observed.
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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Brussels, , Belgium
Céroux-Mousty, , Belgium
Forest, , Belgium
Genk, , Belgium
Gilly, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Liège, , Belgium
Merksem, , Belgium
Besançon, , France
Bordeaux, , France
Clermont-Ferrand, , France
Corbeil, , France
Créteil, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, Herault, , France
Paris, , France
Toulouse, , France
Tours, , France
Athens, , Greece
Heraklion, , Greece
Larissa, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Voula Attica, , Greece
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Den Helder, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Sneek, , Netherlands
Utrecht, , Netherlands
Kemerovo, , Russia
Khabarovsk, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saransk, , Russia
Stavropol, , Russia
Barcelona, , Spain
Bilbao, , Spain
Donostia / San Sebastian, , Spain
Getafe, , Spain
Granada, , Spain
Madrid, , Spain
Mérida, , Spain
Salamanca, , Spain
Valladolid, , Spain
Vitoria-Gasteiz, , Spain
Abergavenny, , United Kingdom
Bath, , United Kingdom
Cambridge, , United Kingdom
Cannock, , United Kingdom
Christchurch, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Reading, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Stoke-on-Trent, , United Kingdom
Wigan, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Alle 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.
Gossec 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.
Van 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.
Gossec 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.
Gossec 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.
Other Identifiers
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CNTO1275PSA4003
Identifier Type: OTHER
Identifier Source: secondary_id
CR106450
Identifier Type: -
Identifier Source: org_study_id
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