Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03816917 |
| Other study ID # |
NL68137.091.18 |
| Secondary ID |
Nederlands Trial |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
July 28, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Radboud University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
