AsseSSing Impact in pSoriatic Treatment

NCT ID: NCT05171270

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2022-03-22

Brief Summary

Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.

This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.

This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

Detailed Description

This is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with PsA. Participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why.

The study will be conducted in 25 rheumatology centres in Europe (UK, France, Germany, Spain and Italy) with five centres in each country. Each participant will only attend for one single study visit which is likely to last around 30 minutes in total. This will be alongside the participant's routine clinic visit. The PsAID-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper CRFs and transferred to a database for analysis.

Conditions

Psoriatic Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Psoriatic arthritis

Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.

Questionnaire

Intervention Type: OTHER

PsAID questionnaire

Interventions

Questionnaire

PsAID questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language.
• Aged 18 years or above.
• Diagnosed with PsA according to the ClASification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist (Taylor 2006).

Exclusion Criteria

• Patients who don't speak or read the local language
• Patients who are not comfortable filling in an app-based questionnaire or paper CRF.
• Patients with a new diagnosis of PsA at the current clinic visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Gabriel-Montpied

Clermont-Ferrand, , France

Centre Hospitalier Le Mans

Le Mans, , France

Hopitaux Universitaires de Marseille

Marseille, , France

GERPAL, Hopital de la Pitie

Paris, , France

Centre Hospitalier Universitaire (CHU) de Toulouse

Toulouse, , France

Klinikum Bamburg

Bamberg, , Germany

Rheumatologische Schwerpunktpraxis

Berlin, , Germany

Universitatsklinik Frankfurt

Frankfurt, , Germany

Universitätsklinikum der Ruhr-Universität Bochum

Herne, , Germany

MVZ für Rheumatologie Dr. Martin Welcker GmbH

Planegg, , Germany

Ospedale Regionale Cardarelli

Campobasso, , Italy

Complejo Universitario de a Coruña

A Coruña, , Spain

Hospital Clinic (Barcelona)

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, United Kingdom

Cardiff and Vale University LHB

Cardiff, Wales, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, Yorkshire, United Kingdom

Countries

France; Germany; Italy; Spain; United Kingdom

References

Watson L, Coyle C, Whately-Smith C, Brooke M, Kiltz U, Lubrano E, Queiro R, Trigos D, Brandt-Juergens J, Choy E, D'Angelo S, Delle Sedie A, Dernis E, Guis S, Helliwell P, Ho P, Hueber AJ, Joven B, Koehm M, Montilla C, Packham J, Pinto Tasende JA, Ramirez Garcia FJ, Ruyssen-Witrand A, Scrivo R, Twigg S, Soubrier M, Wirth T, Gossec L, Coates LC. An international multicentre analysis of current prescribing practices and shared decision-making in psoriatic arthritis. Rheumatology (Oxford). 2024 Dec 1;63(12):3449-3456. doi: 10.1093/rheumatology/kead621.

Reference Type: DERIVED

PMID: 38011669 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

287039

Identifier Type: -

Identifier Source: org_study_id