Status:
UNKNOWN
Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)
Lead Sponsor:
Professor Mikkel Østergaard
Collaborating Sponsors:
Celgene Corporation
The Danish Rheumatism Association
Conditions:
Psoriasis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 mo...
Detailed Description
Part 1: A population-based survey of Danish inhabitants, will by screening of approximately 10.000 Danes identify approximately 425 persons who report to have psoriasis(PsO) with or without psoriatic...
Eligibility Criteria
Inclusion
- 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
- 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, lactase deficiency or glucose-galactose
- malabsorption
- Severe renal failure (glomerular filtration rate (GFR) \<30ml/min)
- Current treatment with potent CYP3A4 enzyme inhibitors (rifampicin, phenobarbital, carbamazepin, phenytoin, perikon ("grønne lykkepiller" , Neurokan, Modigen, Calmigen, Velzina))
- Current or planned (during the study period) treatment that might cause psychiatric symptoms
- Known active tuberculosis (TB) or history of incompletely treated TB.
- Clinical history of serious liver disease.
- Hepatitis B antigen positivity or Hepatitis C antibodies positivity at screening (tests ≤3 months before inclusion is accepted).
- Bacterial infections requiring antibiotics (oral or intravenously) or serious viral or fungal infections within the last four weeks before screening. Treatment of such infections should be completed 4 weeks prior to screening.
- Clinical history of serious immunological disease (including HIV or other congenital or acquired immune disease) or other serious uncontrolled disease.
- Current depression, previous depression, previous suicidal thoughts/tendencies or psychiatric symptoms
- Conditions, including abnormal laboratory measurements, which might put the patient at an unnecessary risk by participation in the study or make data difficult to interpret.
- Known inflammatory rheumatic disease other than PsA.
- MRI substudy: Contraindications for MRI (see appendix 22.2.2)
- Certain previous and concomitant treatment
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04515732
Start Date
December 14 2018
End Date
October 1 2021
Last Update
August 17 2020
Active Locations (2)
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1
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
2
Dansk Gigthospital
Sønderborg, Denmark, 6400