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   June 20, 2024 - 21:08

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OVERVIEW

  • Gender
    all
  • Age
    6 - 17 years
  • Phase
    - phase
  • Sites
    30 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

Locations in:
United Kingdom, Switzerland, Russia, Norway, Netherlands, Greece, Germany, France, Denmark, Belgium, Austria
Country (11) City or Province (30) Status
United Kingdom Cardiff, CRF University Hospital of Wales
COMPLETED
United Kingdom London Great Ormond Street Hospital
COMPLETED
United Kingdom London Whipps Cross University Hospital
ACTIVE_NOT_RECRUITING
United Kingdom Salford Salford Royal Hospital
COMPLETED
Switzerland Zürich, ZH Kinderspital Zürich
RECRUITING
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
Netherlands Nijmegen, GE Radboudumc
RECRUITING
Greece Athens Andreas Sygros Hospital
RECRUITING
Greece Thessaloniki University Hospital for Skin and Venereal Diseases
RECRUITING
Germany Langenau, BW Praxis Dr. med. Beate Schwarz - Germany
COMPLETED
Germany Mainz Gemeinschaftspraxis Dres. Quist
COMPLETED
Germany Mainz, RP Universitätsmedizin der Johannes Gutenberg-Universität Mainz
COMPLETED
France Argenteuil CH Victor Dupouy Argenteuil
RECRUITING
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
Belgium Bruxelles, BRU UCL Hopital Saint-Luc
COMPLETED
Belgium Leuven UZ Leuven
RECRUITING
Belgium Liege CHU de Liège - Domaine Universitaire du Sart Tilman
COMPLETED
Belgium Loverval, WHT Grand Hôpital de Charleroi
COMPLETED
Austria Graz Uniklinik Graz
RECRUITING
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