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

• Status: Enrolling by invitation
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Mikkel Østergaard
• Collaborators: Celgene Corporation; The Danish Psoriasis Association; The Danish Rheumatism Association
• Treatments: Apremilast

Criteria

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