Brief Summary

Rationale: Psoriasis (PsO) is a common inflammatory skin disease. Besides the skin, it is recognized that this disease can affect multiple domains such as nails, joints and entheses. About 30% of the patients with PsO will develop symptoms in the musculoskeletal domains. Untreated inflammation in psoriatic arthritis (PsA) can lead to irreversible joint damage and further reduces quality of life. Since musculoskeletal involvement is often preceded by the dermatological symptoms of PsO, patients with pure cutaneous psoriasis (PsC) should be routinely screened for joint involvement. Current screening questionnaires, like the often used Psoriasis Epidemiology Screening Tool (PEST), offer a moderate discrimination between patients with PsA and PsC at best. Our aim is to assert the prevalence of known and previously undiagnosed PsA in a PsC cohort. By comparing the gathered data of the PsA and PsC patients, we hope to improve the screening of PsC patients, and to reduce both undertreatment of locomotor symptoms as well as unnecessary diagnostic investigations. Objective: To ascertain the prevalence of PsA in a tertiary PsO cohort. Secondary objectives will be to ascertain the clinical features of these patients. With these features we want to find clinical, laboratory or genetic markers to predict the presence of PsA in PsO patients. Moreover, we wish to establish the added value of PsA screening for the quality of life (QoL) of PsO patients. Study design: Multicenter cross-sectional study with a single follow-up visit after 1 year. Patients will be screened at baseline for PsA symptoms by a rheumatology resident and referred to a rheumatology clinic if deemed necessary. At baseline, several clinical and sociodemographic parameters will be assessed. We will collect blood samples for diverse biochemical studies and genomic DNA. Patients will be followed for 1 year after active screening for PsA. Quality of life (QoL) and treatment change will be recorded after this period, to assess the effect of screening and referral.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

304

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

December 27, 2018

Completed

29 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed

4 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed

Last Updated

July 29, 2022

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

December 27, 2018

Last Update Submit

July 28, 2022

Conditions

Psoriasis Psoriatic Arthritis Psoriasis Vulgaris Psoriatic Nail

Keywords

ScreeningPrediction Model

Outcome Measures

Primary Outcomes (1)

Presence of PsA according to CASPAR-criteria
The CASPAR-criteria are positive if a patient has inflammatory enthesitis OR peripheral OR axial arthritis AND cutaneous psoriasis (all of our patients) AND 1 additional outcome (see outcome 2 to 6)
at baseline

Secondary Outcomes (9)

Presence of dactylitis
at baseline
Absence of rheumatoid factor
at baseline
Presence of new bone formation
at baseline
Presence of typical psoriatic nail disease
at baseline
Presence of typical psoriatic nail disease
at baseline
+4 more secondary outcomes

Other Outcomes (5)

Comorbidity
at baseline
Comorbidity
at baseline
Degree of cutaneous involvement
at baseline
+2 more other outcomes

Study Arms (3)

topical treatment

100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy)

Other: cutaneous parameters of psoriasis (exposure)Other: comorbidity (exposure)Other: family history (exposure)Other: lifestyle (exposure)Other: patient reported outcomes (exposure)Other: inflammatory markers (exposure)Other: genetic (exposure)

systemic treatment

100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted.

biologics

100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy with biologics. Other systemic and topical therapy is permitted.

Interventions

cutaneous parameters of psoriasis (exposure)OTHER

characteristic of the cutaneous domains of the psoriasis: age at start, disease duration, current and previous treatment PASI, BSA, nail involvement