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Набира участници Фаза 3 NCT04804553

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Active Juvenile Psoriatic Arthritis

Спонсор: Amgen

Налично на: БГ
Обобщение
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.
Кой може да участва
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).
Интервенции
Apremilast
DRUG
Placebo
DRUG
Места на провеждане 45
Австрия (1)
Landeskrankenhaus Bregenz
Bregenz
Белгия (3)
Universitair Ziekenhuis Gent
Ghent
TERMINATED
Centre Hospitalier Regional de la Citadelle
Liège
TERMINATED
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem
TERMINATED
Франция (2)
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron
Hopital Jeanne de Flandre
Lille
Германия (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
Гърция (3)
Agia Sofia Children Hospital
Athens
Attikon University General Hospital
Athens
General Hospital of Thessaloniki Ippokrateio
Thessaloniki
Италия (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
Нидерландия (1)
Universitair Medisch Centrum Utrecht
Utrecht
Полша (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
Португалия (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
Румъния (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
Испания (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
Турция (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
Великобритания (4)
Birmingham Childrens Hospital
Birmingham
TERMINATED
Alder Hey Childrens Hospital
Liverpool
TERMINATED
Nottingham Childrens Hospital
Nottingham
John Radcliffe Hospital
Oxford
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
5 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
17.03.2022
Крайна дата
29.12.2028
Регистрационен номер
NCT04804553
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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