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Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER)

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ClinicalTrials.gov Identifier: NCT03816917
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Sint Maartenskliniek
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment
Psoriasis Psoriatic Arthritis Psoriasis Vulgaris Psoriatic Nail Other: cutaneous parameters of psoriasis (exposure) Other: comorbidity (exposure) Other: family history (exposure) Other: lifestyle (exposure) Other: patient reported outcomes (exposure) Other: inflammatory markers (exposure) Other: genetic (exposure)

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Psoriasis

Group/Cohort Intervention/treatment
topical treatment
100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy)
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

systemic treatment
100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted.
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

biologics
100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy with biologics. Other systemic and topical therapy is permitted.
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




Primary Outcome Measures :
  1. Presence of PsA according to CASPAR-criteria [ Time Frame: at baseline ]
    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)


Secondary Outcome Measures :
  1. Presence of dactylitis [ Time Frame: at baseline ]
    Dactylitis count, range 0-20, yes/no

  2. Absence of rheumatoid factor [ Time Frame: at baseline ]
    A rheumatoid factor measured in serum: U/mL, yes/no below the cutoff point as set by the local lab

  3. Presence of new bone formation [ Time Frame: at baseline ]
    X-rays of hand and feet as judged by the local radiologist, presence of new bone formation yes/no

  4. Presence of typical psoriatic nail disease [ Time Frame: at baseline ]
    NAPSI

  5. Presence of typical psoriatic nail disease [ Time Frame: at baseline ]
    N-NAIL

  6. The presence of clinical enthesitis [ Time Frame: at baseline ]
    Leeds Enthesitis Index, scored 0-6

  7. The presence of arthritis [ Time Frame: at baseline ]
    66 Swollen Joint Count, 0-66, yes/no

  8. The presence of arthralgia [ Time Frame: at baseline ]
    68 Tender Joint Count, 0-66, yes/no

  9. The presence of inflammatory back pain [ Time Frame: at baseline ]
    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


Other Outcome Measures:
  1. Comorbidity [ Time Frame: at baseline ]
    Score on Charlson Comorbidity Scale

  2. Comorbidity [ Time Frame: at baseline ]
    Score on Functional Comorbidity Index

  3. Degree of cutaneous involvement [ Time Frame: at baseline ]
    PASI

  4. Degree of cutaneous involvement [ Time Frame: at baseline ]
    Body surface (in percentage)

  5. Quality of Life [ Time Frame: at baseline and after 12 months ]
    Short Form 36 scores, DLQI scores, PsAID12 scores


Biospecimen Retention:   Samples With DNA
  • serum
  • plasma
  • DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cutaneous psoriasis, treated at a third line university outpatient dermatology clinic. Patients will be stratified based on current therapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816917


Contacts
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Contact: Tamara van Hal, MD t.vanhal@maartenskliniek.nl
Contact: Juul van den Reek, MD PhD juul.vandenreek@radboudumc.nl

Sponsors and Collaborators
Radboud University
Sint Maartenskliniek
Investigators
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Principal Investigator: Elke de Jong, Prof MD PhD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03816917     History of Changes
Other Study ID Numbers: NL68137.091.18
Nederlands Trial Register ( Registry Identifier: NTR7604 )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
Screening
Prediction Model

Additional relevant MeSH terms:
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Psoriasis
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases