PsoriasisDAPPERNCT03816917
Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral
An observational study of Psoriasis and Psoriatic Arthritis, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis, Psoriasis Vulgaris
- What is being tested?
- cutaneous parameters of psoriasis (exposure), comorbidity (exposure) and family history (exposure)
- How many people
- 304 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2019to 28 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cutaneous psoriasis, treated at a third line university outpatient dermatology clinic. Patients will be stratified based on current therapy.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study
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.
Read the 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.
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriasis Vulgaris, Psoriatic Nail
- Being tested
- cutaneous parameters of psoriasis (exposure), comorbidity (exposure), family history (exposure), lifestyle (exposure), patient reported outcomes (exposure)
- Keywords
- Screening, Prediction Model
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| topical treatment | 100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy) Receives: 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) | |
| systemic treatment | 100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted. Receives: 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) | |
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of PsA according to CASPAR-criteria
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)
Measured: at baseline
Secondary outcomes (9)
Presence of dactylitis
Dactylitis count, range 0-20, yes/no
Measured: at baseline
Absence of rheumatoid factor
A rheumatoid factor measured in serum: U/mL, yes/no below the cutoff point as set by the local lab
Measured: at baseline
Presence of new bone formation
X-rays of hand and feet as judged by the local radiologist, presence of new bone formation yes/no
Measured: at baseline
Presence of typical psoriatic nail disease
NAPSI
Measured: at baseline
Presence of typical psoriatic nail disease
N-NAIL
Measured: at baseline
The presence of clinical enthesitis
Leeds Enthesitis Index, scored 0-6
Measured: at baseline
The presence of arthritis
66 Swollen Joint Count, 0-66, yes/no
Measured: at baseline
The presence of arthralgia
68 Tender Joint Count, 0-66, yes/no
Measured: at baseline
The presence of inflammatory back pain
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
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2021
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sint Maartenskliniek
- Responsible party
- Sponsor
- Investigators
- Elke de Jong, Prof MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816917
- Sponsor's protocol ID
- NL68137.091.18
- Other IDs
- Nederlands Trial Register
- Acronym
- DAPPER
- Status last verified
- Jul 2021
- First submitted
- 27 Dec 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03816917
- Acronym / sponsor ID
- DAPPER / NL68137.091.18
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriasis Vulgaris, Psoriatic Nail
- Keywords
- Screening, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Sint Maartenskliniek
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| topical treatment | – | 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)100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: only topical/UV therapy (no systemic therapy) |
| systemic treatment | – | 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)100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy, but no biologicals. Topical therapy is permitted. |
| biologics | – | 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)100 consecutive patients with cutaneous psoriasis, stratified on current therapy for cutaneous symptoms: systemic therapy with biologics. Other systemic and topical therapy is permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cutaneous psoriasis, treated at a third line university outpatient dermatology clinic. Patients will be stratified based on current therapy.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | biologics, systemic treatment, topical treatment |
| comorbidity (exposure)medical and medication history, current and previous comorbidity | Other | biologics, systemic treatment, topical treatment |
| family history (exposure)Family history of PsC, PsA, IBD, AS, and uveitis | Other | biologics, systemic treatment, topical treatment |
| lifestyle (exposure)* Intoxications * Lifestyle: occupation and injuries, sport and physical hobbies | Other | biologics, systemic treatment, topical treatment |
| patient reported outcomes (exposure)VAS-score on fatigue, PsC severity, joint pain and general well-being | Other | biologics, systemic treatment, topical treatment |
| inflammatory markers (exposure)Measurements of inflammatory and bone remodeling markers in serum and plasma | Other | biologics, systemic treatment, topical treatment |
| genetic (exposure)Assessment of known HLA- and SNP-associations with PsA or PsA | Other | biologics, systemic treatment, topical treatment |
Primary outcome
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)
9 secondary outcomes
Presence of dactylitis
Time frame: at baseline
Absence of rheumatoid factor
Time frame: at baseline
Presence of new bone formation
Time frame: at baseline
Presence of typical psoriatic nail disease
Time frame: at baseline
Presence of typical psoriatic nail disease
Time frame: at baseline
The presence of clinical enthesitis
Time frame: at baseline
The presence of arthritis
Time frame: at baseline
The presence of arthralgia
Time frame: at baseline
The presence of inflammatory back pain
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elke de Jong, Prof MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Psoriatic Arthritis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of PsA according to CASPAR-criteria (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.