Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04515732
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04515732
Study Brief:
Protocol Section:
NCT04515732