Clinical Trials in Italy / NCT04804553
Recruiting
Phase 3
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
NCT04804553 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Active Juvenile Psoriatic Arthritis
Investigational drug(s) / intervention(s)
Apremilast →Placebo
Apremilast: Participants will receive apremilast orally.
Placebo: Participants will receive the matching placebo orally.
Study summary
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
Eligibility
Inclusion Criteria:
* Male or Female participants 5 to \< 18 years of age at the time of randomization.
* Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
* Arthritis and psoriasis, OR
* Arthritis with at least 2 of the following:
* Dactylitis
* Nail pitting or onycholysis
* Psoriasis in a first-degree relative
* Active disease: at least 3 active joints.
* Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate \[MTX\] or biologic agents).
Exclusion Criteria:
* Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
* Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
* Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
* History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
* Presence of systemic juvenile idiopathic arthritis (JIA).
* Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
* Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
Primary outcome measure(s)
- Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16 — Baseline to Week 16
The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]).
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Landeskrankenhaus Bregenz | Bregenz | Austria | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Active Not Recruiting |
| Centre Hospitalier Regional de la Citadelle | Liège | Belgium | Active Not Recruiting |
| Ziekenhuis Netwerk Antwerpen Jan Palfijn | Merksem | Belgium | Active Not Recruiting |
| Hospices Civils de Lyon Hopital Femme Mere Enfant | Bron | France | Recruiting |
| Hopital Jeanne de Flandre | Lille | France | Recruiting |
| Charite - Universitaetsmedizin Berlin, Campus Virchow | Berlin | Germany | Recruiting |
| Universitaetsklinikum Dresden | Dresden | Germany | Terminated |
| An der Schoen Klinik Hamburg Eilbek | Hamburg | Germany | Terminated |
| Asklepios Kinderklinik Sankt Augustin GmbH | Sankt Augustin | Germany | Terminated |
| Agia Sofia Children Hospital | Athens | Greece | Recruiting |
| Attikon University General Hospital | Athens | Greece | Terminated |
| General Hospital of Thessaloniki Ippokrateio | Thessaloniki | Greece | Recruiting |
| Ospedale Santissima Annunziata | Chieti | Italy | Terminated |
| IRCCS Istituto Giannina Gaslini | Genova | Italy | Terminated |
| Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini | Milan | Italy | Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | Italy | Terminated |
| Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine | Vilnius | Lithuania | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
| Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie | Krakow | Poland | Active Not Recruiting |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lodz | Poland | Active Not Recruiting |
| Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warsaw | Poland | Active Not Recruiting |
| Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz | Lisbon | Portugal | Terminated |
| Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos | Ponte de Lima | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao | Porto | Portugal | Terminated |
| Unidade Local de Saude de Gaia-Espinho, EPE | Vila Nova de Gaia | Portugal | Recruiting |
| Spitalul Clinic de Urgenta pentru Copii Cluj | Cluj-Napoca | Romania | Terminated |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara | Timișoara | Romania | Recruiting |
| Panorama Medical Centre | Panorama | Western Cape | Recruiting |
| Groote Schuur Hospital | Cape Town | South Africa | Terminated |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Canary Islands | Recruiting |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | Recruiting |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Catalonia | Recruiting |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Terminated |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | Turkey (Türkiye) | Recruiting |
+ 5 more sites — see the full list on the official registry below.
On this site
📄 Otezla (apremilast) drug profile →More Amgen trials in Italy
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04804553 on ClinicalTrials.gov ↗ ← All trials in Italy