A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis

NCT02627768 | Completed

• 2 other identifiers: CR106450CNTO1275PSA4003
• Study Type: observational
• Target: 991
• Locations: 7 countries
• Sites: 66

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.

Conditions

Psoriatic Arthritis

Keywords

STELARA; Psoriatic Arthritis; Ustekinumab

Outcome Measures

Primary Outcomes (22)

• Time to Drug Stop or Switch

  Time taken to stop or switch the study drug is evaluated.

  Up to Month 36

• Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Month 36

  The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0 = no disease activity to 100 = maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 less than or equal to (\<=) 3.2 or a change from Baseline less than (\<) -1.2. EULAR Moderate response: DAS28 greater than (\>) 3.2 to \<= 5.1 or a change from Baseline \< -0.6 to greater than or equal to (\>=) -1.2.

  Baseline and Month 36

• Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Scores at Month 36

  The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on visual analog scale (VAS) (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Joints assessed include the distal interphalangeal (DIP), proximal interphalangeal (PIP), and metacarpophalangeal (MCP) joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and PIP joints of the feet. CRP level in milligrams per deciliters (mg/dL). Cut-off values for low and high disease activity are \<= 14 and \> 28 points, respectively, and for remission is \<= 4 points.

  Baseline and Month 36

• Percentage of Participants Achieving Low Disease Activity Based on DAPSA Score

  The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Cut-off values for low and high disease activity are \<= 14 and \> 28 points, respectively, and for remission is \<= 4 points.

  Month 36

• Percentage of Participants Achieving Remission Based on DAPSA Score

  The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Cut-off values for low and high disease activity are \<= 14 and \> 28 points, respectively, and for remission is \<= 4 points.

  Month 36

• Change From Baseline in Physician's Global Assessment of Disease Activity (PGA-PsA) Measured on a Visual Analogue Scale at Month 36

  Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).

  Baseline and Month 36

• Change From Baseline in Patient Global Assessment of Disease Activity (PtGA) at Month 36

  The PtGA VAS is a self-administered assessment with scores ranging from "very well" (0 mm) to "very poor" (100 mm) that assesses disease activity over the past week. Proposed categories for interpretation of the VAS score: \<10 mm, low disease activity; \>= 10 millimeter (mm) but \<30 mm moderate disease activity; \>= 30 mm but \<60 mm high disease activity; \>= 60 mm very high disease activity.

  Baseline and Month 36

• Percentage of Participants with Dactylitis Over Time

  The total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.

  Up to Month 36

• Percentage of Participants with Enthesitis Over Time

  Enthesitis will be documented using the Leeds Enthesitis Index (LEI). The LEI examination points include the lateral epicondyle (left and right), medial femoral condyle (left and right), and Achilles tendon insertion (left and right).

  Up to Month 36

• Change From Baseline in Nail Involvement Scores (Number Of Nails) at Month 36

  Nail involvement will be evaluated by recording the total number of nails of the hands and feet (that is, 0 to 20) with PsA involvement.

  Baseline and Month 36

• Change From Baseline in C-Reactive Protein (CRP) at Month 36

  C-Reactive Protein will be evaluated to measure the inflammation.

  Baseline and Month 36

• Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 36

  Erythrocyte Sedimentation Rate will be evaluated to measure the inflammation.

  Baseline and Month 36

• Percentage of Participants With Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement

  Psoriasis skin involvement will be documented using categories: \<3 percentage (%), 3% to 10%, and \>10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.

  Month 36

• Change From Baseline in Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement at Month 36

  Psoriasis skin involvement will be documented using categories: \<3%, 3% to 10%, and \>10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.

  Baseline and Month 36

• Percentage Change From Baseline in EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3L) Scores at Month 36

  The EQ-5D-3L is a standardized measure of health status developed by the EuroQoL Group to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical economic evaluation of health care. The EQ 5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems.

  Baseline and Month 36

• Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 36

  The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.

  Baseline and Month 36

• Percentage of Participants Achieving in the Health Assessment Questionnaire Disability Index (HAQ-DI) Response

  The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.

  Month 36

• Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Month 36

  The PsAID-12 is a validated, self-administered questionnaire developed by EULAR for use in clinical practice that assesses the impact of PsA on participants' lives. It consists of 12 questions, each answered using a numerical rating scale. Questions related to pain, skin problems, work and/or leisure activities, discomfort, embarrassment and/or shame, social participation, and anger, fear, and uncertainty; and depression are scored from 0 (none) to 10 (extreme), functional capacity and sleep disturbance are scored from 0 (no difficulty) and 10 (extreme difficulty) and coping is scored from 0 (very well) 10 (very poorly).

  Baseline and Month 36

• Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Month 36

  The pain VAS is a self-administered assessment of average pain during the past week. The scale ranges from "no pain" (0 mm) to "the worst possible pain" (100 mm). This assessment should be completed prior to the tender and swollen joint examination.

  Baseline and Month 36

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores at Month 36

  The BASDAI participant rated components over last 48 hours using 100 mm Visual Analog Scale; components 15: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness sub-scale.

  Baseline and Month 36

• Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI:PsA) Scores at Month 36

  The WPAI:PsA is a validated, self-administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI:PsA produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on the job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI: PsA outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.

  Baseline and Month 36

• Percentage of Participants With Change in Employment Status

  Change in the employment status of participants will be evaluated.

  Month 36

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Serious AEs

  Screening up to follow-up (Approximately Month 39)

Study Arms (2)

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.

Drug: No Intervention

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.

Drug: No Intervention

Interventions

No Intervention DRUG

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 1: Ustekinumab Treatment; Cohort 2: TNFi Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (66)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Céroux-Mousty, Belgium

Location

Unknown Facility

Forest, Belgium

Location

Unknown Facility

Genk, Belgium

Location

Unknown Facility

Gilly, Belgium

Location

Unknown Facility

Hasselt, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Merksem, Belgium

Location

Unknown Facility

Besançon, France

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Clermont-Ferrand, France

Location

Unknown Facility

Corbeil, France

Location

Unknown Facility

Créteil, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Montpellier, Herault, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Heraklion, Greece

Location

Unknown Facility

Larissa, Greece

Location

Unknown Facility

Pátrai, Greece

Location

Unknown Facility

Thessaloniki, Greece

Location

Unknown Facility

Voula Attica, Greece

Location

Unknown Facility

Alkmaar, Netherlands

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Den Helder, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Sneek, Netherlands

Location

Unknown Facility

Utrecht, Netherlands

Location

Unknown Facility

Kemerovo, Russia

Location

Unknown Facility

Khabarovsk, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Saransk, Russia

Location

Unknown Facility

Stavropol, Russia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Bilbao, Spain

Location

Unknown Facility

Donostia / San Sebastian, Spain

Location

Unknown Facility

Getafe, Spain

Location

Unknown Facility

Granada, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Mérida, Spain

Location

Unknown Facility

Salamanca, Spain

Location

Unknown Facility

Valladolid, Spain

Location

Unknown Facility

Vitoria-Gasteiz, Spain

Location

Unknown Facility

Abergavenny, United Kingdom

Location

Unknown Facility

Bath, United Kingdom

Location

Unknown Facility

Cambridge, United Kingdom

Location

Unknown Facility

Cannock, United Kingdom

Location

Unknown Facility

Christchurch, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Metropolitan Borough of Wirral, United Kingdom

Location

Unknown Facility

Reading, United Kingdom

Location

Unknown Facility

Salford, United Kingdom

Location

Unknown Facility

Sheffield, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

Unknown Facility

Wigan, United Kingdom

Location

Unknown Facility

Wolverhampton, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 39547694 DERIVED

• 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.

  PMID: 37353788 DERIVED

• 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.

  PMID: 36810788 DERIVED

• 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.

  PMID: 36600178 DERIVED

• 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.

  PMID: 35210262 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: December 17, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

GB (16); FR (12); GR (6); BE (9); NL (7); RU (6); ES (10)