A Long-term Extension Study of Ustekinumab in Pediatric Participants (NCT05092269) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Long-term Extension Study of Ustekinumab in Pediatric Participants
United States, Argentina159 participantsStarted 2021-10-18
Plain-language summary
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have completed the dosing planned in the primary pediatric ustekinumab study
* Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
* Parent(s) (preferably both if available or as per local requirements), legal guardian(s) 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 (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
* Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration
Exclusion Criteria:
* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19…
What they're measuring
1
Number of Participants With Adverse Events (AEs)
Timeframe: Up to 6 years and 4 months
2
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to 6 years and 4 months
3
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Timeframe: Up to 6 years and 4 months
4
Number of Participants with AEs of Interest
Timeframe: Up to 6 years and 4 months
5
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Timeframe: Up to 6 years and 4 months
6
Number of Participants with Injection-site Reactions
Timeframe: Up to 6 years and 4 months
7
Number of Participants With AEs of Worsening of the Disease
Timeframe: Up to 6 years and 4 months
8
Number of Participants With Concomitant Therapy due to Loss of Response