Phase
Condition
Psoriatic Arthritis
Joint Injuries
Treatment
Placebo
Apremilast
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 monthsduration:
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 (including distal interphalangeal joints).
Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifyinganti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologicagents).
Exclusion
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'ssyndrome, acute anterior uveitis, or a history of one of these disorders in afirst-degree relative
History of IgM rheumatoid factor on at least 2 occasions at least 3 monthsapart
Presence of systemic juvenile idiopathic arthritis (JIA).
Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, butnot 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).
Study Design
Connect with a study center
Landeskrankenhaus Bregenz
Bregenz, 6900
AustriaActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
Centre Hospitalier Regional de la Citadelle
Liege, 4000
BelgiumTerminated
Ziekenhuis Netwerk Antwerpen Jan Palfijn
Merksem, 2170
BelgiumTerminated
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron cedex, 69677
FranceActive - Recruiting
Hopital Jeanne de Flandre
Lille, 59037
FranceActive - Recruiting
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353
GermanyActive - Recruiting
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum
Berlin, 13353
GermanyActive - Recruiting
Universitaetsklinik Carl Gustav Carus
Dresden, 01307
GermanyActive - Recruiting
Universitaetsklinikum Dresden
Dresden, 01307
GermanyActive - Recruiting
An der Schoen Klinik Hamburg Eilbek
Hamburg, 22081
GermanyActive - Recruiting
Asklepios Kinderklinik Sankt Augustin GmbH
Sankt Augustin, 53757
GermanyCompleted
Agia Sofia Children Hospital
Athens, 11527
GreeceActive - Recruiting
Attikon University General Hospital
Athens, 12462
GreeceActive - Recruiting
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, 54642
GreeceActive - Recruiting
Ospedale Santissima Annunziata
Chieti, 66100
ItalyActive - Recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
Milano, 20122
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalyActive - Recruiting
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
Vilnius, 08406
LithuaniaActive - Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 EA
NetherlandsActive - Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
Krakow, 31-503
PolandActive - Recruiting
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 91-738
PolandActive - Recruiting
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa, 02-637
PolandActive - Recruiting
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisboa, 1349-019
PortugalActive - Recruiting
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisboa, 1349-019
PortugalActive - Recruiting
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar Universtario de Sao Joao, EPE
Porto, 4200-319
PortugalActive - Recruiting
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319
PortugalTerminated
Spitalul Clinic de Urgenta pentru Copii Cluj
Cluj-Napoca, 400124
RomaniaActive - Recruiting
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Timisoara, 300011
RomaniaActive - Recruiting
Panorama Medical Centre
Panorama, Western Cape 7500
South AfricaActive - Recruiting
Groote Schuur Hospital
Cape Town, 7700
South AfricaTerminated
Hospital Universitario de Canarias
La Laguna, Canarias 38320
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainActive - Recruiting
Hospital Sant Joan de Deu
Esplugues De Llorbregat, Cataluña 08950
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Comunidad Valenciana 46026
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainTerminated
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100
TurkeyActive - Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
TurkeyActive - Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
TurkeyActive - Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093
TurkeyActive - Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093
TurkeyActive - Recruiting
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34764
TurkeyActive - Recruiting
Birmingham Childrens Hospital
Birmingham, B4 6NH
United KingdomActive - Recruiting
Alder Hey Childrens Hospital
Liverpool, L12 2AP
United KingdomTerminated
Nottingham Childrens Hospital
Nottingham, NG7 2UH
United KingdomActive - Recruiting
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