<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816917</url>
  </required_header>
  <id_info>
    <org_study_id>NL68137.091.18</org_study_id>
    <secondary_id>Nederlands Trial Register</secondary_id>
    <nct_id>NCT03816917</nct_id>
  </id_info>
  <brief_title>Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral</brief_title>
  <acronym>DAPPER</acronym>
  <official_title>Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sint Maartenskliniek</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Psoriasis (PsO) is a common inflammatory skin disease. Besides the skin, it is&#xD;
      recognized that this disease can affect multiple domains such as nails, joints and entheses.&#xD;
      About 30% of the patients with PsO will develop symptoms in the musculoskeletal domains.&#xD;
      Untreated inflammation in psoriatic arthritis (PsA) can lead to irreversible joint damage and&#xD;
      further reduces quality of life. Since musculoskeletal involvement is often preceded by the&#xD;
      dermatological symptoms of PsO, patients with pure cutaneous psoriasis (PsC) should be&#xD;
      routinely screened for joint involvement. Current screening questionnaires, like the often&#xD;
      used Psoriasis Epidemiology Screening Tool (PEST), offer a moderate discrimination between&#xD;
      patients with PsA and PsC at best. Our aim is to assert the prevalence of known and&#xD;
      previously undiagnosed PsA in a PsC cohort. By comparing the gathered data of the PsA and PsC&#xD;
      patients, we hope to improve the screening of PsC patients, and to reduce both undertreatment&#xD;
      of locomotor symptoms as well as unnecessary diagnostic investigations.&#xD;
&#xD;
      Objective: To ascertain the prevalence of PsA in a tertiary PsO cohort. Secondary objectives&#xD;
      will be to ascertain the clinical features of these patients. With these features we want to&#xD;
      find clinical, laboratory or genetic markers to predict the presence of PsA in PsO patients.&#xD;
      Moreover, we wish to establish the added value of PsA screening for the quality of life (QoL)&#xD;
      of PsO patients.&#xD;
&#xD;
      Study design: Multicenter cross-sectional study with a single follow-up visit after 1 year.&#xD;
      Patients will be screened at baseline for PsA symptoms by a rheumatology resident and&#xD;
      referred to a rheumatology clinic if deemed necessary. At baseline, several clinical and&#xD;
      sociodemographic parameters will be assessed. We will collect blood samples for diverse&#xD;
      biochemical studies and genomic DNA. Patients will be followed for 1 year after active&#xD;
      screening for PsA. Quality of life (QoL) and treatment change will be recorded after this&#xD;
      period, to assess the effect of screening and referral.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a monocenter cohort study, which will span at least 1 year from inclusion to&#xD;
      follow-up.&#xD;
&#xD;
      A sample of 300 patients known with PsC (cutaneous psoriasis) at the Department of&#xD;
      Dermatology of the RadboudUMC, Nijmegen will be included. Inclusion of patients and&#xD;
      collection of samples will be performed adjacent to their regular outpatient visits.&#xD;
&#xD;
      During screening, patients will be assessed for signs and symptoms of PsA (psoriatic&#xD;
      arthritis). This will include a 68 tender joint count (TJC) and 66 swollen joint count (SJC),&#xD;
      a dactylitis count, the Leeds enthesis index (LEI) and a questionnaire screening for&#xD;
      inflammatory back pain (IBP).&#xD;
&#xD;
      At baseline visit, different parameters will be noted which can later be used to construct&#xD;
      the prediction model. These will include sociodemographic data, relevant comorbidity, family&#xD;
      history, characteristics of the PsC, intoxications, and constitutional and specific&#xD;
      rheumatological signs and symptoms. During physical examination, the investigators will&#xD;
      gather information about body measurements, skin and nail parameters, and rheumatological&#xD;
      parameters.&#xD;
&#xD;
      Also, a screening questionnaires already in use (PEST) will be used, as well as a quality of&#xD;
      life scores (PsAID12, DLQI, Short-Form 12 Health Survey/SF-12).&#xD;
&#xD;
      Blood will be drawn at baseline to check for different laboratory parameters which are&#xD;
      associated with presence of PsA. Both inflammatory markers (e.g. cytokines, chemokines) as&#xD;
      markers associated with bone metabolism are of interest. Also, DNA will be gathered via&#xD;
      saliva and stored. At a later moment, this will be used to investigate the predictive value&#xD;
      of different associated genetic polymorphisms and HLA-associations.&#xD;
&#xD;
      If there is a clinical suspicion of PsA in the clinical exam, the patient will be referred to&#xD;
      the Department of Rheumatology of the Sint Maartenskliniek, Nijmegen (SMK). From there on,&#xD;
      they will be included in PsA regular care. After 1 year, patient files of the referred&#xD;
      patients will be checked to confirm the diagnosis. Also, treatment changes and their effect&#xD;
      will be noted. This will include both clinical parameters of the PsA and QoL.&#xD;
&#xD;
      Patients already treated for PsA at a different clinic will not be referred to the SMK. They&#xD;
      will be asked for permission to retrieve treatment-related data from their treating&#xD;
      physician.&#xD;
&#xD;
      Patients without musculoskeletal involvement will be re-evaluated after 1 year. Again,&#xD;
      treatment changes and quality of life will be monitored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">July 28, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of PsA according to CASPAR-criteria</measure>
    <time_frame>at baseline</time_frame>
    <description>The CASPAR-criteria are positive if a patient has inflammatory enthesitis OR peripheral OR axial arthritis AND cutaneous psoriasis (all of our patients) AND 1 additional outcome (see outcome 2 to 6)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of dactylitis</measure>
    <time_frame>at baseline</time_frame>
    <description>Dactylitis count, range 0-20, yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of rheumatoid factor</measure>
    <time_frame>at baseline</time_frame>
    <description>A rheumatoid factor measured in serum: U/mL, yes/no below the cutoff point as set by the local lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of new bone formation</measure>
    <time_frame>at baseline</time_frame>
    <description>X-rays of hand and feet as judged by the local radiologist, presence of new bone formation yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of typical psoriatic nail disease</measure>
    <time_frame>at baseline</time_frame>
    <description>NAPSI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of typical psoriatic nail disease</measure>
    <time_frame>at baseline</time_frame>
    <description>N-NAIL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The presence of clinical enthesitis</measure>
    <time_frame>at baseline</time_frame>
    <description>Leeds Enthesitis Index, scored 0-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The presence of arthritis</measure>
    <time_frame>at baseline</time_frame>
    <description>66 Swollen Joint Count, 0-66, yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The presence of arthralgia</measure>
    <time_frame>at baseline</time_frame>
    <description>68 Tender Joint Count, 0-66, yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The presence of inflammatory back pain</measure>
    <time_frame>at baseline</time_frame>
    <description>ASAS criteria for inflammatory back pain are positive is there is back pain for more than 3 months, and 4/5 of the following parameters are positive: age of onset &lt;40 year, gradual development, improvement with exercise, no improvement with rest and back pain at night which improves on getting up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comorbidity</measure>
    <time_frame>at baseline</time_frame>
    <description>Score on Charlson Comorbidity Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Comorbidity</measure>
    <time_frame>at baseline</time_frame>
    <description>Score on Functional Comorbidity Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Degree of cutaneous involvement</measure>
    <time_frame>at baseline</time_frame>
    <description>PASI</description>
  </other_outcome>
  <other_outcome>
    <measure>Degree of cutaneous involvement</measure>
    <time_frame>at baseline</time_frame>
    <description>Body surface (in percentage)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>at baseline and after 12 months</time_frame>
    <description>Short Form 36 scores, DLQI scores, PsAID12 scores</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">304</enrollment>
  <condition>Psoriasis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Psoriasis Vulgaris</condition>
  <condition>Psoriatic Nail</condition>
  <arm_group>
    <arm_group_label>topical treatment</arm_group_label>
    <description>100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>systemic treatment</arm_group_label>
    <description>100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>biologics</arm_group_label>
    <description>100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy with biologics. Other systemic and topical therapy is permitted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cutaneous parameters of psoriasis (exposure)</intervention_name>
    <description>characteristic of the cutaneous domains of the psoriasis: age at start, disease duration, current and previous treatment PASI, BSA, nail involvement</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>comorbidity (exposure)</intervention_name>
    <description>medical and medication history, current and previous comorbidity</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>family history (exposure)</intervention_name>
    <description>Family history of PsC, PsA, IBD, AS, and uveitis</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lifestyle (exposure)</intervention_name>
    <description>Intoxications&#xD;
Lifestyle: occupation and injuries, sport and physical hobbies</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patient reported outcomes (exposure)</intervention_name>
    <description>VAS-score on fatigue, PsC severity, joint pain and general well-being</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inflammatory markers (exposure)</intervention_name>
    <description>Measurements of inflammatory and bone remodeling markers in serum and plasma</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>genetic (exposure)</intervention_name>
    <description>Assessment of known HLA- and SNP-associations with PsA or PsA</description>
    <arm_group_label>biologics</arm_group_label>
    <arm_group_label>systemic treatment</arm_group_label>
    <arm_group_label>topical treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  serum&#xD;
&#xD;
        -  plasma&#xD;
&#xD;
        -  DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cutaneous psoriasis, treated at a third line university outpatient&#xD;
        dermatology clinic. Patients will be stratified based on current therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cutaneous psoriasis&#xD;
&#xD;
          -  Age 18 years or above&#xD;
&#xD;
          -  Willing and able to comply with visits and study-related procedures&#xD;
&#xD;
          -  Provide signed informed consent (IC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  Unable to give IC&#xD;
&#xD;
          -  Unable or unwilling to comply with visits and study-related procedures&#xD;
&#xD;
          -  Participation in other trials involving PsO&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elke de Jong, Prof MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Screening</keyword>
  <keyword>Prediction Model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816917
org study id: NL68137.091.18
secondary id: Nederlands Trial Register
nct id: NCT03816917
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Presence of PsA according to CASPAR-criteria
time frame: at baseline
description: The CASPAR-criteria are positive if a patient has inflammatory enthesitis OR peripheral OR axial arthritis AND cutaneous psoriasis (all of our patients) AND 1 additional outcome (see outcome 2 to 6)
measure: Presence of dactylitis
time frame: at baseline
description: Dactylitis count, range 0-20, yes/no
measure: Absence of rheumatoid factor
time frame: at baseline
description: A rheumatoid factor measured in serum: U/mL, yes/no below the cutoff point as set by the local lab
measure: Presence of new bone formation
time frame: at baseline
description: X-rays of hand and feet as judged by the local radiologist, presence of new bone formation yes/no
measure: Presence of typical psoriatic nail disease
time frame: at baseline
description: NAPSI
measure: Presence of typical psoriatic nail disease
time frame: at baseline
description: N-NAIL
measure: The presence of clinical enthesitis
time frame: at baseline
description: Leeds Enthesitis Index, scored 0-6
measure: The presence of arthritis
time frame: at baseline
description: 66 Swollen Joint Count, 0-66, yes/no
measure: The presence of arthralgia
time frame: at baseline
description: 68 Tender Joint Count, 0-66, yes/no
measure: The presence of inflammatory back pain
time frame: at baseline
description: ASAS criteria for inflammatory back pain are positive is there is back pain for more than 3 months, and 4/5 of the following parameters are positive: age of onset <40 year, gradual development, improvement with exercise, no improvement with rest and back pain at night which improves on getting up
measure: Comorbidity
time frame: at baseline
description: Score on Charlson Comorbidity Scale
measure: Comorbidity
time frame: at baseline
description: Score on Functional Comorbidity Index
measure: Degree of cutaneous involvement
time frame: at baseline
description: PASI
measure: Degree of cutaneous involvement
time frame: at baseline
description: Body surface (in percentage)
measure: Quality of Life
time frame: at baseline and after 12 months
description: Short Form 36 scores, DLQI scores, PsAID12 scores
arm group label: topical treatment
description: 100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy)
arm group label: systemic treatment
description: 100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted.
arm group label: biologics
description: 100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy with biologics. Other systemic and topical therapy is permitted.
intervention type: Other
intervention name: cutaneous parameters of psoriasis (exposure)
description: characteristic of the cutaneous domains of the psoriasis: age at start, disease duration, current and previous treatment PASI, BSA, nail involvement
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: comorbidity (exposure)
description: medical and medication history, current and previous comorbidity
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: family history (exposure)
description: Family history of PsC, PsA, IBD, AS, and uveitis
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: lifestyle (exposure)
description: Intoxications
Lifestyle: occupation and injuries, sport and physical hobbies
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: patient reported outcomes (exposure)
description: VAS-score on fatigue, PsC severity, joint pain and general well-being
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: inflammatory markers (exposure)
description: Measurements of inflammatory and bone remodeling markers in serum and plasma
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
intervention type: Other
intervention name: genetic (exposure)
description: Assessment of known HLA- and SNP-associations with PsA or PsA
arm group label: biologics
arm group label: systemic treatment
arm group label: topical treatment
-  serum

        -  plasma

        -  DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elke de Jong, Prof MD PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Psoriasis
sharing ipd: Undecided