Phase
Condition
Psoriatic Arthritis
Inflammatory Bowel Disease
Joint Injuries
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
Changzhou No 2 Peoples Hospital
Changzhou, 213003
ChinaActive - Recruiting
Kobe University Hospital
Kobe, 650 0017
JapanActive - Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861 8520
JapanActive - 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
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainActive - Recruiting
University of Utah
Salt Lake City, Utah 84113
United StatesActive - Recruiting
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