A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis (STELARA)
Last Updated   January 31, 2024 - 20:06
OVERVIEW
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Gender
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Age
years -
Phase
phase -
Sites
sites -
Status
Recruiting
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).
CONDITIONS
- Psoriasis
ELIGIBILITY
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
DETAILS
LOCATIONS
Country (11) | City or Province (30) | Status |
United Kingdom | Cardiff, CRF University Hospital of Wales |
COMPLETED
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United Kingdom | London Great Ormond Street Hospital |
COMPLETED
|
United Kingdom | London Whipps Cross University Hospital |
RECRUITING
|
United Kingdom | Salford Salford Royal Hospital |
COMPLETED
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Switzerland | Zürich, ZH Kinderspital Zürich |
RECRUITING
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Russia | Moscow FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences |
COMPLETED
|
Russia | Moscow Moscow Research-Practical Center of Dermatovenerology and Cosmetology |
COMPLETED
|
Russia | Omsk Llc Ultramed |
COMPLETED
|
Russia | Sankt-Peterburg Saint-Petersburg State Pediatric Medical Academy of RosZdrav |
COMPLETED
|
Norway | Oslo, OL Oslo universitetssykehus HF, Rikshospitalet |
RECRUITING
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Netherlands | Nijmegen, GE Radboudumc |
RECRUITING
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Greece | Athens Andreas Sygros Hospital |
RECRUITING
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Greece | Thessaloniki University Hospital for Skin and Venereal Diseases |
RECRUITING
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Germany | Langenau, BW Praxis Dr. med. Beate Schwarz - Germany |
COMPLETED
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Germany | Mainz Gemeinschaftspraxis Dres. Quist |
COMPLETED
|
Germany | Mainz, RP Universitätsmedizin der Johannes Gutenberg-Universität Mainz |
COMPLETED
|
France | Argenteuil CH Victor Dupouy Argenteuil |
RECRUITING
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France | Besançon Cedex CHRU Besancon Hopital Jean Minjoz |
RECRUITING
|
France | Bordeaux Groupe Hospitalier Pellegrin CHU de Bordeaux |
RECRUITING
|
France | Brest Cedex 2 ICH Hopital A. Morvan |
COMPLETED
|
France | Martigues Le Bateau Blanc |
COMPLETED
|
France | Paris Cedex 15 Hôpital Necker Enfants Malades |
COMPLETED
|
France | Saint-Etienne Cedex 2 CHU Saint-Etienne - Hopital Nord |
RECRUITING
|
Denmark | Copenhagen Bispebjerg Hospital |
COMPLETED
|
Denmark | Hellerup Gentofte Herlev Hospital |
RECRUITING
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Belgium | Bruxelles, BRU UCL Hopital Saint-Luc |
COMPLETED
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Belgium | Leuven UZ Leuven |
RECRUITING
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Belgium | Liege CHU de Liège - Domaine Universitaire du Sart Tilman |
COMPLETED
|
Belgium | Loverval, WHT Grand Hôpital de Charleroi |
COMPLETED
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Austria | Graz Uniklinik Graz |
RECRUITING
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