AsseSSing Impact in pSoriatic Treatment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05171270
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Oxford
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries France, Germany, Italy, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

: Psoriatic arthritis

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

Interventions

Other: - Questionnaire

PsAID questionnaire

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Gabriel-Montpied, Clermont-Ferrand, France

Status

Recruiting

Address

CHU Gabriel-Montpied

Clermont-Ferrand, , 63000

Site Contact

Martin Soubrier

msoubrier@chu-clermontferrand.fr

07870257823

Centre Hospitalier Le Mans, Le Mans, France

Status

Recruiting

Address

Centre Hospitalier Le Mans

Le Mans, ,

Site Contact

Emmanuelle Dernis

edernis@ch-lemans.fr

07870257823

Hopitaux Universitaires de Marseille, Marseille, France

Status

Recruiting

Address

Hopitaux Universitaires de Marseille

Marseille, ,

Site Contact

Sandrine Guis

sandrine.guis@ap-hm.fr

07870257823

GERPAL, Hopital de la Pitie, Paris, France

Status

Recruiting

Address

GERPAL, Hopital de la Pitie

Paris, , 75651

Site Contact

Laure Gossec

laura.gossec@aphp.fr

07870257823

Toulouse, France

Status

Recruiting

Address

Centre Hospitalier Universitaire (CHU) de Toulouse

Toulouse, ,

Site Contact

Adeline Ruyssen-Witrand

ruyssen-witrand.a@chu-toulouse.fr

07870257823

Klinikum Bamburg, Bamberg, Germany

Status

Recruiting

Address

Klinikum Bamburg

Bamberg, ,

Site Contact

Axel Hueber

laura.coates@ndorms.ox.ac.uk

07870257823

Rheumatologische Schwerpunktpraxis, Berlin, Germany

Status

Recruiting

Address

Rheumatologische Schwerpunktpraxis

Berlin, ,

Site Contact

Jan Brandt-Jurgens

laura.coates@ndorms.ox.ac.uk

07870257823

Universitatsklinik Frankfurt, Frankfurt, Germany

Status

Recruiting

Address

Universitatsklinik Frankfurt

Frankfurt, ,

Site Contact

Michaela Kohm

laura.coates@ndorms.ox.ac.uk

07870257823

Herne, Germany

Status

Recruiting

Address

Universitätsklinikum der Ruhr-Universität Bochum

Herne, ,

Site Contact

Uta Kiltz

uta.kiltz@elisabethgruppe.de

07870257823

Planegg, Germany

Status

Recruiting

Address

MVZ für Rheumatologie Dr. Martin Welcker GmbH

Planegg, ,

Site Contact

Martin Welcker

laura.coates@ndorms.ox.ac.uk

07870257823

Ospedale Regionale Cardarelli, Campobasso, Italy

Status

Recruiting

Address

Ospedale Regionale Cardarelli

Campobasso, ,

Site Contact

Ennio Lubrano

enniolubrano@hotmail.com

07870257823

Hospital Clinic (Barcelona), Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Clinic (Barcelona)

Barcelona, ,

Site Contact

Julio Ramiez Garcia

julramga@gmail.com

07870257823

Complejo Universitario de a Coruña, Coruña, Spain

Status

Not yet recruiting

Address

Complejo Universitario de a Coruña

Coruña, ,

Site Contact

Jose Antonio Pinto

jose.antonio.pinto.tasende@sergas.es

07870257823

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, ,

Site Contact

Beatriz Joven Ibanez

beatrizjoven@hotmail.com

07870257823

Oviedo, Spain

Status

Not yet recruiting

Address

Hospital Universitario Central de Asturias

Oviedo, ,

Site Contact

Ruben Queiro

rubenque7@yahoo.es

07870257823

Hospital Universitario de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hospital Universitario de Salamanca

Salamanca, ,

Site Contact

Carlos Montilla Morales

montillamorales.carlos@gmail.com

07870257823

Manchester, Greater Manchester, United Kingdom

Status

Recruiting

Address

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL

Site Contact

Pauline Ho

pauline.ho@mft.nhs.uk

07870257823

Oxford, Oxfordshire, United Kingdom

Status

Recruiting

Address

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX39DU

Site Contact

Laura C Coates, MBChB

laura.coates@ndorms.ox.ac.uk

07870257823

Stafford, Staffordshire, United Kingdom

Status

Not yet recruiting

Address

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, ST16 3SR

Site Contact

Jon Packham

jon.packham@mpft.nhs.uk

07870257823

Cardiff and Vale University LHB, Cardiff, Wales, United Kingdom

Status

Recruiting

Address

Cardiff and Vale University LHB

Cardiff, Wales, CF14 4HH

Site Contact

Ernest Choy

choyEH@cardiff.ac.uk

07870257823

Bradford, Yorkshire, United Kingdom

Status

Recruiting

Address

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, Yorkshire, BD9 6RJ

Site Contact

Sarah Twigg

sarah.twigg@bthft.nhs.uk

07870257823

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