Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP) (NCT04515732) | Clinical Trial Compass
UnknownPhase 4
Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)
Denmark115 participantsStarted 2018-12-14
Plain-language summary
3-part study of patients with psoriasis, including 1) a population based questionnaire 2) cross-sectional clinical study with focus on musculoskeletal ultrasound and patient reported outcomes 3) 12 months follow-up study of patients with certain ultrasonic signs of psoriatic arthritis. Patients with pain: Interventional with 6 months treatment with apremilast, followed by 6 months observation. Patients without pain: 12 months observation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
In general (all parts of the study):
* Age \>18 years
* Being able and willing to comply with the requirements of this protocol
* Having signed informed consent
Part 2:
• Psoriasis, diagnosed by a physician according to patient
Part 3a:
* Musculoskeletal pain in relation to joints or entheses (that is not explained by alternative diagnosis, as assessed by including rheumatologist) and"US-defined PsA" (ie. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))
* MRI substudy:
* Clinical dactylitis or enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)
* No contraindications for MRI (see appendix 22.2.2) For allowed and disallowed previous and concomitant treatment, please see paragraph on "Previous and concomitant medication".
Part 3b:
• Not having musculoskeletal pain but still "US-defined PsA" (i.e. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))
Exclusion Criteria:
In general (all parts of study):
• Incapability of complying with the examination program of this protocol for physical, mental or practical reasons.
Part 2:
• Incapability of understanding spoken or written danish.
Part 3a:
* Pregnancy, pregnancy wish or breast-feeding.
* Hypersensitivity to the active substance (apremilast) or any of the excipients.
* Hereditary problems of galactose intolerance, lac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with PsO reporting musculoskeletal pain within the past 12 months
Timeframe: 1 day (At completion of questionnaire (performed once))
2
The difference in number of joints with US defined synovitis, in PsO patients with, compared to patients without musculoskeletal pain.
Timeframe: Day 0
3
The difference in number of entheses with US defined enthesitis, in PsO patients with, compared to patients without musculoskeletal pain.
Timeframe: Day 0
4
Change in OMERACT-EULAR Global US score of synovitis, from baseline to 6 months, in patients treated with apremilast (intervention group).