Psoriasis and psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Otezla
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: apremilast
CAS Number: 608141-41-9
Other descriptive name: APREMILAST
Concentration unit: mg milligram(s)
Concentration
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion 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: o Clinical dactylitis or enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis) o No 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study has three parts, described under sub-studies. Main objective for the cross-sectional parts (part 1 and 2): To quantify and describe a psoriasis (Pso )patient population with regards to musculoskeletal pain, the prevalence and pattern of clinical and US signs of inflammation in joints and entheses, and their impact on patient’s lives. Main objective for the interventional part (part 3a): To determine the effect of treating psoriatic arthritis (PsA) patients identified in part 2 of the study with apremilast, with respect to decreases in US detected inflammation scores, clinical signs and symptoms and impact on patient’s lives, and the relation between these.;Secondary Objective: Part 1 and 2 -To identify patients within this Pso population, who have PsA by clinical and/or US criteria, which were undiagnosed prior to the study, and to describe the burden of disease and its impact on patient’s lives by clinical, US and patient-reported outcomes. Part 3 -To determine the effect of treating the subgroup of PsA patients identified in part 2, which have dactylitis and/or ankle region enthesitis, with apremilast, with respect to decreases in MRI detected inflammation scores, and clinical signs and symptoms and impact on patient’s lives, and the relation between these. -To investigate if induction therapy with apremilast for 6 months will, also after discontinuation, cause sustained improvements in clinical, US and patient/reported outcomes, or if symptoms and clinical and US findings will reappear, documenting a need for continuous treatment in such patients.;Primary end point(s): Part 1: YouGov Questionnaire (cross-sectional study) Primary outcome The prevalence of musculoskeletal pain in patients with Pso. Part 2: Clinical and US assessments (cross sectional study) Primary outcome The prevalence of synovitis and enthesitis, as defined by US, in patients with Pso with and without musculoskeletal pain. Part 3: 12 month’s follow-up study Pr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1: YouGov Questionnaire Secondary outcomes The correlations between presence of musculoskeletal pain and patient reported outcomes of function, health related quality of life, and impact on patient’s lives (including EQ5D, HAQ and PsAID) Part 2: Clinical and US assessments Secondary outcomes The prevalence of synovitis and enthesitis, as defined by US, at the individual 48 joints and 12 entheseal sites in patients with Pso with and without musculoskeletal pain. The correlation between clinical and US scores of synovitis and enthesitis with patient reported outcomes of pain, function and impact on patient’s lives (including pain, HAQ and PsAID). Sensitivity and specificity of screening questionnaires, with fulfillment of CASPAR criteria as gold standard, and “US defined PsA” as alternative. Part 3: 12 month’s follow-up study Secondary and tertiary outcomes Change in “US total count of inflamed joints and entheses” from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups. Change in patient pain on a VAS, from baseline to 6 months and from 6 to 12 months in intervention group. Change in OMERACT-EULAR Global US score of synovitis from baseline to 3 and 6 months, and from 6 to 12 months, in intervention and non-intervention groups. Change in US enthesitis activity score from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups. Change in PRO’s (including PsAID, HAQ) from baseline to 3, 6, 9 and 12 months. The correlation between changes in clinical and US scores of synovitis and enthesitis and changes in patient reported outcomes of pain, function and impact on patient’s lives (pain, HAQ and PsAID and others), overall and in intervention and non-intervention groups. Change in various composite indices for disease activity and treatment response used in PsA (DAS28-CRP (Disease Activity Score, 28 joints, CRP)(40), PASDAS (Psoriatic Arthritis Dise | — |
Countries
Denmark
Contacts
Public ContactCOPECARE
Copenhagen Center for Arthritis Research (COPECARE) Center for Rheumatology and Spine Diseases, Rigshospitalet
Outcome results
None listed