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A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
Sponsor: Janssen-Cilag International NV
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).
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
135
Start Date
2017-10-25
Completion Date
2032-08-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Ustekinumab
Participants will not receive any intervention as part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice (patients should either start therapy with ustekinumab 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 for the treatment of psoriasis) will be observed for the long-term safety of ustekinumab and the long-term effects of ustekinumab on growth and development.
Locations (30)
Uniklinik Graz
Graz, Austria
UCL Hopital Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Grand Hôpital de Charleroi
Loverval, Belgium
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Herlev Hospital
Hellerup, Denmark
CH Victor Dupouy Argenteuil
Argenteuil, France
CHRU Besancon Hopital Jean Minjoz
Besançon, France
Groupe Hospitalier Pellegrin CHU de Bordeaux
Bordeaux, France
ICH Hopital A. Morvan
Brest, France
Le Bateau Blanc
Martigues, France
Hopital Necker Enfants Malades
Paris, France
CHU Saint Etienne Hopital Nord
Saint-Etienne, France
Praxis Dr. med. Beate Schwarz - Germany
Langenau, Germany
Gemeinschaftspraxis Dres. Quist
Mainz, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, Germany
Andreas Sygros Hospital
Athens, Greece
University Hospital for Skin and Venereal Diseases
Thessaloniki, Greece
Radboudumc
Nijmegen, Netherlands
Oslo universitetssykehus HF, Rikshospitalet
Oslo, Norway
Moscow Research-Practical Center of Dermatovenerology and Cosmetology
Moscow, Russia
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, Russia
Llc Ultramed
Omsk, Russia
Saint-Petersburg State Pediatric Medical Academy of RosZdrav
Saint Petersburg, Russia
Kinderspital Zürich
Zurich, Switzerland
University Hospital of Wales
Cardiff, United Kingdom
Whipps Cross University Hospital
London, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Salford Royal Hospital
Salford, United Kingdom