For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
  2. 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
  3. 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)
  4. Be willing to participate in the study

EXCLUSION CRITERIA

Exclusion Criteria:


Is enrolled in an interventional clinical trial


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Study Locations

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How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Psoriasis

Age (in years)

6 - 17

Participants needed

105

Est. Completion Date

Aug 31, 2032

Treatment type

Observational


Sponsor

Janssen-Cilag International NV

ClinicalTrials.gov identifier

NCT03218488

Study number

CNTO1275PSO4056

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