Phase
Condition
Inflammatory Bowel Disease
Joint Injuries
Crohn's Disease
Treatment
Guselkumab
Clinical Study ID
Ages > 3 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have completed the dosing planned in the primary pediatric guselkumab study
Must have received benefit from continued guselkumab therapy in the opinion of theinvestigator
Before enrollment, a participant must be either: (a) Not of childbearing potential,OR (b) Of childbearing potential and not sexually active, practicing abstinence or ahighly effective method of contraception and agrees to remain on a highly effectivemethod while receiving study intervention and until 12 weeks after the last dose -the end of relevant systemic exposure
Parent(s) (or their legally acceptable representative) must sign an informed consentform (ICF) indicating that he or she understands the purpose of, and proceduresrequired for, the study and is willing to allow the child to participate in thestudy. Assent is required from participants who are capable of understanding thenature of the study, typically those aged 7 years and older, to ensure theirwillingness to participate. An adolescent who provides assent will have theopportunity to sign an adult ICF upon reaching the age of majority, therebyaffirming their understanding of the study's purpose and procedures, as well astheir willingness to participate.
Exclusion
Exclusion Criteria:
Participant is greater than or equal to (>=) 18 years of age and resides in acountry where 2 years have elapsed post marketing authorization for the respectiveadult indication
Participant is <18 years of age and resides in a county where 2 years have elapsedpost marketing authorization for the respective pediatric indication
Are pregnant, nursing, or planning pregnancy or fathering a child
Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
Employee of the investigator or study site, with direct involvement in the proposedstudy or other studies under the direction of that investigator or study site, aswell as family members of the employees or the investigator
Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the participant or that could prevent, limit, or confoundthe protocol-specified assessments
Study Design
Connect with a study center
Instituto Caici
Rosario, S2003CVB
ArgentinaActive - Recruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, 6009
AustraliaActive - Recruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, 4101
AustraliaActive - Recruiting
The Children's Hospital at Westmead
Westmead, 2145
AustraliaActive - Recruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605 020
BrazilActive - Recruiting
Capital Center For Children's health Capital Medical University
Beijing, 100020
ChinaActive - Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, 213003
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016
ChinaActive - Recruiting
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, 310005
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou 1808926, 310016
ChinaActive - Recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
Shengjing Hospital Of China Medical University
Shenyang, 110055
ChinaActive - Recruiting
Hospital Center University De Lille
Lille, 59000
FranceActive - Recruiting
Schon Klinik Hamburg Eilbek
Hamburg, 22081
GermanyActive - Recruiting
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
GermanyActive - Recruiting
ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127
ItalyActive - Recruiting
Azienda USL di Bologna - Ospedale Maggiore
Bologna, 40121
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalyActive - Recruiting
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
ItalyActive - Recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste, 34137
ItalyActive - Recruiting
Tokyo Metropolitan Children's Medical Center
Fuchū, 183 8561
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, 920 8641
JapanActive - Recruiting
Kobe University Hospital
Kobe, 650 0017
JapanActive - Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861 8520
JapanActive - Recruiting
Shinshu University Hospital
Matsumoto, 390 8621
JapanActive - Recruiting
Saga University Hospital
Saga, 849 0937
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama, 232 0024
JapanActive - Recruiting
Korczowski Bartosz Gabinet Lekarski
Rzeszów, 35-302
PolandActive - Recruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, 41 200
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730
PolandActive - Recruiting
Medical Network
Warsaw, 04-501
PolandActive - Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw 756135, 04-730
PolandActive - Recruiting
Medical Network
Warszawa, 04-501
PolandActive - Recruiting
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa, 02 637
PolandSuspended
Uls Braga - Hosp. Braga
Braga, 4710 243
PortugalActive - Recruiting
Uls Sao Joao - Hosp. Sao Joao
Porto, 4200 319
PortugalActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
South KoreaActive - Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainActive - Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainActive - Recruiting
Gazi University Medical Faculty
Ankara, 06560
Turkey (Türkiye)Active - Recruiting
Umraniye Training and Research Hospital
Istanbul, 34764
Turkey (Türkiye)Active - Recruiting
Kocaeli Universitesi Hastanesi
Kocaeli, 41380
Turkey (Türkiye)Active - Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomActive - Recruiting
Haywood Hospital
Stoke-on-Trent, ST6 7AG
United KingdomActive - Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
United KingdomActive - Recruiting
Children's Center for Digestive Healthcare
Atlanta, Georgia 30342
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Riley Hospital for Children
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84113
United StatesActive - Recruiting

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