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Recruiting Phase 3 NCT04804553

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Phase 3 – large-scale trial before approval
Conditions: Active Juvenile Psoriatic Arthritis

Sponsor: Amgen

trial.available_in: БГ
Overview
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.
Who can participate
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).
Interventions
Apremilast
DRUG
Placebo
DRUG
Locations 45
Austria (1)
Landeskrankenhaus Bregenz
Bregenz
Belgium (3)
Universitair Ziekenhuis Gent
Ghent
TERMINATED
Centre Hospitalier Regional de la Citadelle
Liège
TERMINATED
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem
TERMINATED
France (2)
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron
Hopital Jeanne de Flandre
Lille
Germany (4)
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin
Universitaetsklinikum Dresden
Dresden
An der Schoen Klinik Hamburg Eilbek
Hamburg
Asklepios Kinderklinik Sankt Augustin GmbH
Sankt Augustin
COMPLETED
Greece (3)
Agia Sofia Children Hospital
Athens
Attikon University General Hospital
Athens
General Hospital of Thessaloniki Ippokrateio
Thessaloniki
Italy (4)
Ospedale Santissima Annunziata
Chieti
TERMINATED
IRCCS Istituto Giannina Gaslini
Genova
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
Milan
IRCCS Ospedale Pediatrico Bambino Gesu
Roma
Lithuania (1)
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
Vilnius
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht
Poland (3)
Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
Krakow
TERMINATED
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz
TERMINATED
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw
TERMINATED
Portugal (5)
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon
Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
Ponte de Lima
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto
TERMINATED
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia
Romania (2)
Spitalul Clinic de Urgenta pentru Copii Cluj
Cluj-Napoca
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Timișoara
South Africa (2)
Groote Schuur Hospital
Cape Town
TERMINATED
Panorama Medical Centre
Panorama , Western Cape
Spain (6)
Hospital Universitari Vall d Hebron
Barcelona , Catalonia
Hospital Sant Joan de Deu
Esplugues de Llobregat , Catalonia
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario La Paz
Madrid
TERMINATED
Hospital Universitario de Canarias
San Cristóbal de La Laguna , Canary Islands
Hospital Universitari i Politecnic La Fe
Valencia , Valencia
Turkey (4)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul
Umraniye Egitim ve Arastirma Hastanesi
Istanbul
United Kingdom (4)
Birmingham Childrens Hospital
Birmingham
TERMINATED
Alder Hey Childrens Hospital
Liverpool
TERMINATED
Nottingham Childrens Hospital
Nottingham
John Radcliffe Hospital
Oxford
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
5 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
17.03.2022
Completion date
29.12.2028
Registry ID
NCT04804553
Source
clinicaltrials.gov
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