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NCT03218488Active, not recruiting

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

An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
135 (actual)
First submitted
13 Jul 2017
Start date
25 Oct 2017
Primary completion date
31 Aug 2032
Lead sponsor
Janssen-Cilag International NV
Diseases
Psoriasis
NCT number
NCT03218488

What you commit to

  • Study type: Observational
  • Participants enrolled: 135
  • From 25 Oct 2017 to the primary completion date, 31 Aug 2032
  • 30 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Is enrolled in an interventional clinical study

Who the study is looking for

  • 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

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uniklinik Graz
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GrazAustriaUnknown status
UCL Hopital Saint-Luc
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BrusselsBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
CHU de Liège - Domaine Universitaire du Sart Tilman
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LiègeBelgiumUnknown status
Grand Hôpital de Charleroi
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LovervalBelgiumUnknown status
Kinderspital Zürich
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ZurichSwitzerlandUnknown status
Praxis Dr. med. Beate Schwarz - Germany
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LangenauGermanyUnknown status
Gemeinschaftspraxis Dres. Quist
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MainzGermanyUnknown status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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MainzGermanyUnknown status
Bispebjerg Hospital
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CopenhagenDenmarkUnknown status
Gentofte Herlev Hospital
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HellerupDenmarkUnknown status
CH Victor Dupouy Argenteuil
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ArgenteuilFranceUnknown status
CHRU Besançon - Hôpital Jean Minjoz
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BesançonFranceUnknown status
Groupe Hospitalier Pellegrin CHU de Bordeaux
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BordeauxFranceUnknown status
ICH Hopital A. Morvan
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BrestFranceUnknown status
Le Bateau Blanc
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MartiguesFranceUnknown status
Hopital Necker Enfants Malades
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ParisFranceUnknown status
CHU Saint Etienne Hôpital Nord
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Saint-EtienneFranceUnknown status
University Hospital of Wales
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CardiffUnited KingdomUnknown status
Whipps Cross University Hospital
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LondonUnited KingdomUnknown status
Great Ormond Street Hospital
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LondonUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
Andreas Sygros Hospital
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AthensGreeceUnknown status
University Hospital for Skin and Venereal Diseases
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ThessalonikiGreeceUnknown status
Radboudumc
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NijmegenNetherlandsUnknown status
Oslo universitetssykehus HF, Rikshospitalet
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OsloNorwayUnknown status
Moscow Research-Practical Center of Dermatovenerology and Cosmetology
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MoscowRussiaUnknown status
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
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MoscowRussiaUnknown status
Llc Ultramed
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OmskRussiaUnknown status
Saint-Petersburg State Pediatric Medical Academy of RosZdrav
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Saint PetersburgRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.