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…
ID
Source
Brief title
Condition
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of (newly discovered) PsA in known PsO patients in the setting
of a university dermatology outpatient clinic.
Secondary outcome
Secondary endpoints will be the difference between both populations with regard
to several markers. These markers will be used to develop a new screening tool.
QoL parameters, and the change after 1 year, will also be evaluated.
Background summary
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.
Study 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
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.
Study burden and risks
Baseline screening visit will be performed following a planned usual care
outpatient visit. During the screening visit, an oral screening extensive
history taking and physical examination will be performed. Questionnaires
regarding screening (one) and QoL (three) will be taken. Blood samples will be
taken. If treated with systemic therapy, the blood sample can be combined with
regular laboratory tests needed for usual care. Patients with suspected PsA
will be referrred to the rheumatology clinic of the Sint Maartenskliniek for
confirmation of the diagnosis and regular care. After one year, clinical data
will be retrieved from both the dermatologic and rheumatic center. Patients
will be asked to re-evaluate their QoL. Risks associated with this study are
minor. The risk of clinically relevant accidental findings will be discussed
thoroughly during the informed consent.
Geert Grote Plein Zuid 10
Nijmegen 6525 GA
NL
Geert Grote Plein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
* Diagnosis of cutaneous psoriasis
* Age 18 years or above
* Willing and able to comply with visits and study-related procedures
* Provide signed informed consent (IC)
Exclusion criteria
* Age below 18 years
* Unable to give IC
* Unable or unwilling to comply with visits and study-related procedures
* Participation in other trials involving PsO
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL68137.091.18 |
OMON | NL-OMON21407 |