Phase
Condition
Joint Injuries
Psoriatic Arthritis
Treatment
Ustekinumab
Guselkumab
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria withexclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) prior to screening
Active disease in at least greater than or equal to (>=) 3 joints at screening andat week 0 (defined as swelling or loss of motion with pain and/or tenderness.Swelling alone meets the criteria for an active arthritic joint. In the absence ofswelling, loss of motion with pain or tenderness or both pain and tenderness meetthe criteria for an active arthritic joint
Have active disease despite previous non-biologic disease modifying anti-rheumaticdrug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy:Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for atleast 4 weeks or evidence of intolerance
Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids orNSAIDs is permitted but must be on stable dose
Participants must be up to date with all immunizations in agreement with currentlocal immunization guidelines for immunosuppressed patients
Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (exceptnon-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficientwashout period
Exclusion
Exclusion Criteria:
Participants with enthesitis-related arthritis (ERA)
Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
Have a history of, or ongoing, chronic or recurrent infectious disease
Has evidence of herpes zoster infection within 8 weeks prior to Week 0
Have a known history of hepatitis C infection or test positive at screening
Study Design
Connect with a study center
STAT Research S A
Ciudad Autonoma Buenos Aires, C1013AAAB
ArgentinaActive - Recruiting
STAT Research S.A.
Ciudad Autonoma Buenos Aires, C1013AAAB
ArgentinaActive - Recruiting
Hospital de Ninos de Cordoba
Cordoba, 5000
ArgentinaActive - Recruiting
Instituto Medico Platense
La Plata, B1900
ArgentinaActive - Recruiting
Instituto Caici
Rosario, S2000PBJ
ArgentinaActive - Recruiting
Centro Medico Privado de Reumatologia
San Miguel De Tucuman, T4000AXL
ArgentinaActive - Recruiting
Aarhus Universitetshospital
Arhus, 8200
DenmarkActive - Recruiting
Odense Universitets Hospital
Odense, 5000
DenmarkCompleted
CHU de Caen
Caen, 14033
FranceActive - Recruiting
Hopital de Bicetre
Le Kremlin Bicêtre, 94270
FranceActive - Recruiting
Hopital Nord - Marseille
Marseille, 13015
FranceActive - Recruiting
Hopital Nord Marseille
Marseille, 13015
FranceActive - Recruiting
CHU de Toulouse Hopital des Enfants
Toulouse cedex 9, 31059
FranceCompleted
Hôpital D'Enfants
Vandoeuvre les Nancy, 54511
FranceActive - Recruiting
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353
GermanyActive - Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353
GermanyActive - Recruiting
Helios Kliniken Berlin Buch Gmbh
Berlin, 13125
GermanySite Not Available
Schon Klinik Hamburg Eilbek
Hamburg, 22081
GermanyActive - Recruiting
Schön Klinik Hamburg Eilbek
Hamburg, 22081
GermanySite Not Available
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
GermanyActive - Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25100
ItalyActive - Recruiting
Istituto Giannina Gaslini
Genova, 16147
ItalyActive - Recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milano, 20122
ItalyActive - Recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano, 20122
ItalyActive - Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalyActive - Recruiting
Investigación y Biomedicina de Chihuahua
Chihuahua, 31000
MexicoSite Not Available
CREA
Guadalajara, 44100
MexicoSite Not Available
Medical Care & Research SA de CV
Merida, 97070
MexicoSite Not Available
CLIDITER, S.A. de C.V.
México, 06700
MexicoSite Not Available
Erasmus MC
Rotterdam, 3015 GD
NetherlandsSite Not Available
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej
Lodz, 91-738
PolandActive - Recruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, 41 200
PolandActive - Recruiting
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa, 02 637
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa, 02-637
PolandActive - Recruiting
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, 119991
Russian FederationSite Not Available
LLC 'Strategic Medical Systems'
Saint-Petersburg, 192148
Russian FederationSite Not Available
Togliatti City Clinical Hospital#5
Togliatti, 445039
Russian FederationSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 8041
SpainActive - Recruiting
Hosp Reina Sofia
Cordoba, 14004
SpainActive - Recruiting
Hosp. Reina Sofia
Cordoba, 14004
SpainActive - Recruiting
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hosp. Univ. La Paz
Madrid, 28046
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainActive - Recruiting
Hosp. Infanta Luisa
Sevilla, 41010
SpainCompleted
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainActive - Recruiting
Hacettepe Universitesi Hastanesi
Ankara, 6230
TurkeyActive - Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
TurkeyActive - Recruiting
Istanbul University Istanbul Medical Faculty
Istanbul, 34390
TurkeySite Not Available
Umraniye Training and Research Hospital
Istanbul, 34766
TurkeyActive - Recruiting
Kocaeli University Medical Faculty
Kocaeli, 41380
TurkeyActive - Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomSite Not Available
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester, M13 9WL
United KingdomActive - Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United KingdomCompleted
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, S1 0 2TH
United KingdomActive - Recruiting
Southampton General Hospital
Southampton, SO16 6YD
United KingdomActive - Recruiting
Haywood Hospital
Staffordshire, ST6 7AG
United KingdomActive - Recruiting
Royal Stoke University Hospital
Stoke on Trent, ST4 6QG
United KingdomActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Childrens Hospital Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095-3075
United StatesActive - Recruiting
Nemours Children's Hospital/Endocrinology
Orlando, Florida 32827
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637-1447
United StatesSite Not Available
Harvard Medical School - Boston Children's Hospital
Boston, Massachusetts 02215-5450
United StatesSite Not Available
Harvard Medical School - Boston Children's Hospital
Boston, Massachusetts 02215-5450
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467-2403
United StatesActive - Recruiting
Northwell Health
New York, New York 11040
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Metro Health Hospital
Cleveland, Ohio 44109
United StatesSite Not Available
Legacy Emanuel Medical Center
Portland, Oregon 97227
United StatesTerminated
University of Utah
Salt Lake City, Utah 84132
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
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