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Completed

NCT Number: NCT03816917

Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral

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.

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Vulgaris Psoriatic Arthritis Psoriatic Nail Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cutaneous parameters of psoriasis (exposure)

Other

characteristic of the cutaneous domains of the psoriasis: age at start, disease duration, current and previous treatment PASI, BSA, nail involvement

comorbidity (exposure)

Other

medical and medication history, current and previous comorbidity

family history (exposure)

Other

Family history of PsC, PsA, IBD, AS, and uveitis

lifestyle (exposure)

Other
  • Intoxications
  • Lifestyle: occupation and injuries, sport and physical hobbies

patient reported outcomes (exposure)

Other

VAS-score on fatigue, PsC severity, joint pain and general well-being

inflammatory markers (exposure)

Other

Measurements of inflammatory and bone remodeling markers in serum and plasma

genetic (exposure)

Other

Assessment of known HLA- and SNP-associations with PsA or PsA

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Sint Maartenskliniek

Registry information

Official study title

Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study

Acronym: DAPPER

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 25, 2019
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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