Official Title
Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study
Brief Title
Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral
Protocol ID
NCT03816917
Lead Sponsor
Radboud University Medical Center
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.
Detailed Description
This is a monocenter cohort study, which will span at least 1 year from inclusion to
follow-up.
A sample of 300 patients known with PsC (cutaneous psoriasis) at the Department of
Dermatology of the RadboudUMC, Nijmegen will be included. Inclusion of patients and
collection of samples will be performed adjacent to their regular outpatient visits.
During screening, patients will be assessed for signs and symptoms of PsA (psoriatic
arthritis). This will include a 68 tender joint count (TJC) and 66 swollen joint count
(SJC), a dactylitis count, the Leeds enthesis index (LEI) and a questionnaire screening
for inflammatory back pain (IBP).
At baseline visit, different parameters will be noted which can later be used to
construct the prediction model. These will include sociodemographic data, relevant
comorbidity, family history, characteristics of the PsC, intoxications, and
constitutional and specific rheumatological signs and symptoms. During physical
examination, the investigators will gather information about body measurements, skin and
nail parameters, and rheumatological parameters.
Also, a screening questionnaires already in use (PEST) will be used, as well as a quality
of life scores (PsAID12, DLQI, Short-Form 12 Health Survey/SF-12).
Blood will be drawn at baseline to check for different laboratory parameters which are
associated with presence of PsA. Both inflammatory markers (e.g. cytokines, chemokines)
as markers associated with bone metabolism are of interest. Also, DNA will be gathered
via saliva and stored. At a later moment, this will be used to investigate the predictive
value of different associated genetic polymorphisms and HLA-associations.
If there is a clinical suspicion of PsA in the clinical exam, the patient will be
referred to the Department of Rheumatology of the Sint Maartenskliniek, Nijmegen (SMK).
From there on, they will be included in PsA regular care. After 1 year, patient files of
the referred patients will be checked to confirm the diagnosis. Also, treatment changes
and their effect will be noted. This will include both clinical parameters of the PsA and
QoL.
Patients already treated for PsA at a different clinic will not be referred to the SMK.
They will be asked for permission to retrieve treatment-related data from their treating
physician.
Patients without musculoskeletal involvement will be re-evaluated after 1 year. Again,
treatment changes and quality of life will be monitored.
Study Period
-
Enrollment Count
304 participants
Eligibility Criteria
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
Filters
Psoriasis
Psoriatic Arthritis
Psoriasis Vulgaris
Psoriatic Nail
COMPLETED
ADULT
OLDER_ADULT