Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)

Sponsor
Professor Mikkel Østergaard
Study ID
NCT04515732
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 17, 2020
Start date
Dec 14, 2018
Status verified
Aug 2020
Primary completion
Apr 30, 2021
Completion
Oct 31, 2021

Study Design

Enrollment
115 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 3a (apremilast intervention)
    Apremilast in standard dosis (gradual increase 0-30 mg x 2 daily over the first 6 days, hereafter 30 mg x 2 daily) for 6 months, followed by 6 months observation.
  • No Intervention: 3b (non-intervention)
    Observation

Primary Outcome Measure

Number of participants with PsO reporting musculoskeletal pain within the past 12 months [ Time Frame: 1 day (At completion of questionnaire (performed once)) ]

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