A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

  • STATUS
    Recruiting
  • End date
    Aug 31, 2032
  • participants needed
    105
  • sponsor
    Janssen-Cilag International NV
Updated on 15 July 2021
Investigator
The Medical Research Network, LLC
Primary Contact
CHU Saint-Etienne - H pital Nord (2.4 mi away) Contact
+47 other location
body mass index
cancer
ustekinumab
autoimmune disease
plaque psoriasis

Summary

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders
Treatment ustekinumab
Clinical Study IdentifierNCT03218488
SponsorJanssen-Cilag International NV
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
Either start therapy with ustekinumab for the treatment of psoriasis within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study; a. the treatment decision must have been taken independently of and prior to a participant's inclusion in the study; b. where participants have started therapy with ustekinumab before the first assessment in the study, appropriate baseline data at the start of ustekinumab treatment must be documented, including psoriasis area and severity index (PASI), physician global assessment of disease (PGA), body surface area (BSA) and children's dermatology life quality index (CDLQI) scores where available
Participants (and/or a legally-acceptable representative/guardian where applicable) must sign a participation agreement/informed consent form (ICF) allowing source data collection and verification in accordance with local requirements and the participants (and/or a legally-acceptable representative/guardian where applicable) must be able to understand and complete the requested patient-reported outcomes (PROs)
Be willing to participate in the study

Exclusion Criteria

Is enrolled in an interventional clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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