Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral
NCT03816917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 304
Last updated 2022-07-29
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
- Psoriasis
- Psoriatic Arthritis
- Psoriasis Vulgaris
- Psoriatic Nail
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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