Clinical trial NCT02627768: A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: STELARA
Psoriatic Arthritis
Ustekinumab
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 991
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting either STELARA or a new tumor necrosis factor alpha inhibitor (TNFi) as a new therapy in a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.

Brief summary: 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.

Detailed description: This is a prospective, observational, cohort study to collect data on adult participants who have a confirmed diagnosis of psoriatic arthritis (PsA) and are starting either STELARA or a new TNFi as a new therapy in a first, second, or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy. Approximately 1,400 participants will be enrolled into this study, with 700 participants who are receiving STELARA at study entry and 700 participants who are receiving a new TNFi therapy at study entry. Recruitment into the study will continue for approximately 2 years (with the possibility to extend this period if the patient enrollment target is not reached), with a 3-year follow-up period. For each participant, the follow-up period will continue for 3 years (36 months) after inclusion into the study. Participants will primarily be assessed for parameters of treatment retention, clinical response, effectiveness and safety over an observational period of 36 months.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Drug Stop or Switch
timeFrame: Up to Month 36
measure: Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Scores at Month 36
timeFrame: Baseline and Month 36
measure: Percentage of Participants Achieving Low Disease Activity Based on DAPSA Score
timeFrame: Month 36
measure: Percentage of Participants Achieving Remission Based on DAPSA Score
timeFrame: Month 36
measure: Change From Baseline in Physician's Global Assessment of Disease Activity (PGA-PsA) Measured on a Visual Analogue Scale at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Patient Global Assessment of Disease Activity (PtGA) at Month 36
timeFrame: Baseline and Month 36
measure: Percentage of Participants with Dactylitis Over Time
timeFrame: Up to Month 36
measure: Percentage of Participants with Enthesitis Over Time
timeFrame: Up to Month 36
measure: Change From Baseline in Nail Involvement Scores (Number Of Nails) at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in C-Reactive Protein (CRP) at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 36
timeFrame: Baseline and Month 36
measure: Percentage of Participants With Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement
timeFrame: Month 36
measure: Change From Baseline in Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement at Month 36
timeFrame: Baseline and Month 36
measure: Percentage Change From Baseline in EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3L) Scores at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 36
timeFrame: Baseline and Month 36
measure: Percentage of Participants Achieving in the Health Assessment Questionnaire Disability Index (HAQ-DI) Response
timeFrame: Month 36
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores at Month 36
timeFrame: Baseline and Month 36
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI:PsA) Scores at Month 36
timeFrame: Baseline and Month 36
measure: Percentage of Participants With Change in Employment Status
timeFrame: Month 36
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (Approximately Month 39)
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Ceroux-Mousty
country: Belgium
city: Forest
country: Belgium
city: Genk
country: Belgium
city: Gilly
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Merksem
country: Belgium
city: Besancon
country: France
city: Bordeaux N/a
country: France
city: Clermont Ferrand
country: France
city: Corbeil
country: France
city: Creteil
country: France
city: Lille
country: France
city: Lyon cedex 03
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier, Herault
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Larissa
country: Greece
city: Patra
country: Greece
city: Thessaloniki
country: Greece
city: Voula Attica
country: Greece
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Den Helder
country: Netherlands
city: Groningen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sneek
country: Netherlands
city: Utrecht
country: Netherlands
city: Kemerovo
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saransk
country: Russian Federation
city: St.Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Getafe
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Mérida
country: Spain
city: Salamanca
country: Spain
city: San Sebastian
country: Spain
city: Valladolid
country: Spain
city: Vitoria
country: Spain
city: Abergavenny
country: United Kingdom
city: Bath
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Christchurch
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Reading
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Wigan
country: United Kingdom
city: Wirral
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.