Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral

NCT03816917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 304

Last updated 2022-07-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

cutaneous parameters of psoriasis (exposure)

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

OTHER

comorbidity (exposure)

medical and medication history, current and previous comorbidity

OTHER

family history (exposure)

Family history of PsC, PsA, IBD, AS, and uveitis

OTHER

lifestyle (exposure)

* Intoxications * Lifestyle: occupation and injuries, sport and physical hobbies

OTHER

patient reported outcomes (exposure)

VAS-score on fatigue, PsC severity, joint pain and general well-being

OTHER

inflammatory markers (exposure)

Measurements of inflammatory and bone remodeling markers in serum and plasma

OTHER

genetic (exposure)

Assessment of known HLA- and SNP-associations with PsA or PsA

Sponsors & Collaborators

  • Sint Maartenskliniek

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Elke de Jong, Prof MD PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-07-01
Completion
2022-07-28

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816917 on ClinicalTrials.gov