HIPPOCRATES Prospective Observational Study

NCT05858528 | Recruiting

• 1 other identifier: 325080
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which will run across Europe. The study will be led by a research team at University of Oxford and supported by a team at University College Dublin. We are aiming to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. We want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. We are recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires will include a 'screening questionnaire' to try to identify arthritis. If participants are identified by the 'screening questionnaire' as having possible arthritis, they will be advised to seek local medical help. We will follow up with them to see if they are diagnosed with psoriatic arthritis. Alongside the questionnaire information from participants, we will ask some participants to provide a blood fingerprick sample using an easy to use at home sampling kit. The blood sample will be posted to a central location (University College Dublin) where it will be stored and then studied in the laboratory to look for markers that may predict the onset of arthritis. As many (most) participants will not develop arthritis, we are also studying the impact of psoriasis on the participants to learn more about how psoriasis affects people's daily lives across Europe.

Conditions

Psoriatic Arthritis; Psoriasis

Keywords

prognosis; prediction

Outcome Measures

Primary Outcomes (1)

• Diagnosis of PsA

  Development of PsA confirmed by upload of clinic letter confirming diagnosis. As this is a pragmatic study, this will be a local rheumatologist and so the expertise of the physician may vary.

  Up to 3 years

Secondary Outcomes (5)

• Impact of disease in psoriasis

  Up to 3 years

• Functional impact of psoriasis

  Up to 3 years

• Depression prevalence in psoriasis

  Up to 3 years

• Fatigue impact in psoriasis

  Up to 3 years

• Burden of treatment in psoriasis

  Up to 3 years

Study Arms (1)

Observational

No intervention in this study

Diagnostic Test: PEST screening questionnaire

Interventions

PEST screening questionnaire DIAGNOSTIC_TEST

PEST questionnaire to screen for PsA performed every 6 months

Observational

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

Adults with psoriasis but no pre-existing diagnosis of PsA.

You may qualify if:

• Adult ≥18 years
• Self-reported diagnosis of skin psoriasis (any form)
• Participant is willing and able to give informed consent for participation in the study and complete data in one of the HPOS languages

You may not qualify if:

• Pre-existing diagnosis of PsA

Sponsors & Collaborators

• University of Oxford: lead
• University College Dublin: collaborator

Study Sites (1)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX39DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bio-samples will be collected from a sub-set of consenting study participants who have either developed PsA or selected study participants who have been identified to be at low or high risk of PsA (using predictive models developed in other studies). Patient centric bio-sample collection will be achieved using self-administered fingerprick blood sampling kits.

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Laura C Coates, MBChB, PhD

CONTACT

01865737838; laura.coates@ndorms.ox.ac.uk

Study Design

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

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: June 27, 2023
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: April 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GB (1)