Prevalence, disease pattern and -course of arthritis and enthesitis in patients with psoriasis, as well as the effect of apremilast treatment on inflammatory changes found by ultrasound examinatio

Phase 1

• Conditions: Psoriasis and psoriatic arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-004354-15-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-20
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 425

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) andUS-defined PsA” (ie. with certain joint and/or entheseal inflammation as documented by US (see ‘Definitions of patient populations’ for definition))
•MRI substudy:
oClinical dactylitis or enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)
oNo contraindications for MRI
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’ in protocol for definition))
Patients that fulfill the inclusion criteria for part 3, but also fulfill some exclusion criteria for part 3a, but not for 3b, may be included in part 3b.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 325
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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.
•Bacterial infections requirering 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 aqiured 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
Part 3b:
•Known inflammatory rheumatic disease other than PsA.

For allowed and disallaowed medications, please see protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified