A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
NCT ID: NCT03218488
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
135 participants
OBSERVATIONAL
2017-10-25
2032-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants 6-17 years of Age With Moderate to Severe Plaque Psoriasis
All Participants diagnosed with moderate to severe plaque psoriasis who will 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 as per routine clinical practice, will be monitored for the long-term safety of ustekinumab and long-term effects of ustekinumab on growth and development. The primary data source for the study will be the medical records of participants and standardized questionnaires (completed by the physician and by the participant/parent).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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Janssen-Cilag International NV
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag International NV Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag International NV
Locations
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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
Countries
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Other Identifiers
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CNTO1275PSO4056
Identifier Type: OTHER
Identifier Source: secondary_id
CR108277
Identifier Type: -
Identifier Source: org_study_id
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