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

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT02627768

Acronym / sponsor ID

PsaBio / CR106450

Conditions

Psoriatic Arthritis

Keywords

STELARA, Psoriatic Arthritis, Ustekinumab

Study type

Observational

Recruitment status

Completed

Enrolment

991 participants (actual)

Lead sponsor

Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)

Study start

17 Dec 2015 (actual)

Primary completion

31 Dec 2020 (actual)

Study completion

31 Dec 2020 (actual)

First posted

11 Dec 2015 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Time to Drug Stop or Switch

   Time frame: Up to Month 36

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

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

   Time frame: Baseline and 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.

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

   Time frame: Baseline and 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.

4. Percentage of Participants Achieving Low Disease Activity Based on DAPSA Score

   Time frame: 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 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.

5. Percentage of Participants Achieving Remission Based on DAPSA Score

   Time frame: 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 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.

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

   Time frame: Baseline and 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).

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

   Time frame: Baseline and 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.

8. Percentage of Participants with Dactylitis Over Time

   Time frame: Up to Month 36

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

9. Percentage of Participants with Enthesitis Over Time

   Time frame: Up to Month 36

   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).

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Month 36

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

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

    Time frame: Baseline and Month 36

    Erythrocyte Sedimentation Rate will be evaluated to measure the inflammation.

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

    Time frame: Month 36

    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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: 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.

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

22. Percentage of Participants With Change in Employment Status

    Time frame: Month 36

    Change in the employment status of participants will be evaluated.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
• Derived from this study: PubMed 39547694Alle 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.
• Derived from this study: PubMed 37353788Gossec 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.
• Derived from this study: PubMed 36810788Van 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.
• Derived from this study: PubMed 36600178Gossec 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.
• Derived from this study: PubMed 35210262Gossec 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.

Related trials for Psoriatic Arthritis

• Not yet recruitingPhase 2

  Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)

  Moderate to Severe Psoriatic Arthritis

• Recruiting

  Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis

  Rhumatoid Arthisis, Spondyloarthritis (SA)

• RecruitingPhase 1

  A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

  Psoriatic Arthritis, Axial Spondyloarthritis

• RecruitingPhase 4

  Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial

  Psoriatic Arthritis (PsA)

• Active, not recruitingPhase 3

  Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

  Psoriatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

66 sites in 7 countries: see every site and its status.