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

This is an interventional diagnostic trial for Psoriasis focused on measuring Ultrasound, Patient reported outcome measures Read More

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, 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