Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants - U-POPS (Ustekinumab Pediatric Opportunistic PK Study)

Janssen Research & Development, LLC0 个研究点开始时间: 2024年5月6日最近更新: 2024年5月13日

适应症

试验速览

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•Age and Disease Characteristics
•1. =5 to <18 years of age, inclusive, with a diagnosis of jPsA (ie, ILAR or Vancouver criteria) by qualified HCP.
•=6 to <18 years of age, inclusive, with a diagnosis of pediatric PsO by a qualified HCP.
•Type of Participant
•2. Initiated ustekinumab treatment =16 weeks prior to enrollment and received 3 or more doses of ustekinumab prior to enrollment.
•Informed Consent
•3. Parent(s) (preferably both if available or as per local requirements) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 75
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any potential participant who meets any of the following criteria will be excluded from
•participating in the study.
•1. Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
•2. Has any condition that, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
•3. If currently enrolled in an investigational study, contact the Study Responsible Physician to discuss eligibility for inclusion in study.

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