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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniklinik Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| UCL Hopital Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHU de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Grand Hôpital de Charleroi Coordinator of this site? Confirm its status | Loverval | Belgium | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Praxis Dr. med. Beate Schwarz - Germany Coordinator of this site? Confirm its status | Langenau | Germany | Unknown status |
| Gemeinschaftspraxis Dres. Quist Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Gentofte Herlev Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Unknown status |
| CH Victor Dupouy Argenteuil Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| CHRU Besançon - Hôpital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Groupe Hospitalier Pellegrin CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| ICH Hopital A. Morvan Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Le Bateau Blanc Coordinator of this site? Confirm its status | Martigues | France | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Saint Etienne Hôpital Nord Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Whipps Cross University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Andreas Sygros Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University Hospital for Skin and Venereal Diseases Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Oslo universitetssykehus HF, Rikshospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Moscow Research-Practical Center of Dermatovenerology and Cosmetology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Llc Ultramed Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Saint-Petersburg State Pediatric Medical Academy of RosZdrav Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.