A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
STELARA
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
2 other identifiers
observational
135
11 countries
30
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2032
April 13, 2026
April 1, 2026
14.9 years
July 13, 2017
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. All participants will be monitored for the long-term safety of ustekinumab for the frequency and severity of adverse events potentially related to immune modulation and of clinical interest such as: serious infections, malignancies, and autoimmunity.
Baseline up to end of data collection ((maximum of 8 years)
Evaluation of Growth: Height
Growth will be based on height recorded at baseline and throughout the observational period.
Baseline up to end of data collection (maximum of 8 years)
Evaluation of Growth: Weight
Growth will be based on body weight recorded at baseline and throughout the observational period.
Baseline up to end of data collection (maximum of 8 years)
Evaluation of Growth: Body Mass Index (BMI)
Growth will be based on body weight recorded at baseline and throughout the observational period. Sex and age adjusted BMI will be calculated by dividing the body weight (in kilograms) by the square of height (in meters).
Baseline up to end of data collection (maximum of 8 years)
Sexual Maturity Based on the Tanner scale
The Tanner scale is used to measure visible changes during puberty commonly referred to as "Tanner stages". It has 3 components: breasts/genitalia, pubic hair, and growth. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for development of external genitalia and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics).
Baseline up to end of data collection (maximum of 8 years)
Secondary Outcomes (7)
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response
Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 75 Response
Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 90 Response
Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of 0 or 1
Baseline up to end of data collection (maximum of 8 years)
Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis
Baseline up to end of data collection (maximum of 8 years)
- +2 more secondary outcomes
Study Arms (1)
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).
Interventions
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.
Eligibility Criteria
The study population consists of pediatric participants (6 years to 17 years of age at the time of inclusion) with a diagnosis of moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice.
You may qualify if:
- Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
- 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
You may not qualify if:
- Is enrolled in an interventional clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Uniklinik Graz
Graz, 8036, Austria
UCL Hopital Saint-Luc
Brussels, 1200, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Grand Hôpital de Charleroi
Loverval, 6280, Belgium
Bispebjerg Hospital
Copenhagen, NV 2400, Denmark
Gentofte Herlev Hospital
Hellerup, 2800, Denmark
CH Victor Dupouy Argenteuil
Argenteuil, 95107, France
CHRU Besancon Hopital Jean Minjoz
Besançon, 25030, France
Groupe Hospitalier Pellegrin CHU de Bordeaux
Bordeaux, 33076, France
ICH Hopital A. Morvan
Brest, 29609, France
Le Bateau Blanc
Martigues, 13500, France
Hopital Necker Enfants Malades
Paris, 75743, France
CHU Saint Etienne Hopital Nord
Saint-Etienne, 42055, France
Praxis Dr. med. Beate Schwarz - Germany
Langenau, 89129, Germany
Gemeinschaftspraxis Dres. Quist
Mainz, 55128, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131, Germany
Andreas Sygros Hospital
Athens, 16121, Greece
University Hospital for Skin and Venereal Diseases
Thessaloniki, 54 643, Greece
Radboudumc
Nijmegen, 6525 EX, Netherlands
Oslo universitetssykehus HF, Rikshospitalet
Oslo, 0027, Norway
Moscow Research-Practical Center of Dermatovenerology and Cosmetology
Moscow, 119049, Russia
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, 119991, Russia
Llc Ultramed
Omsk, 644024, Russia
Saint-Petersburg State Pediatric Medical Academy of RosZdrav
Saint Petersburg, 194353, Russia
Kinderspital Zürich
Zurich, 8032, Switzerland
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 14, 2017
Study Start
October 25, 2017
Primary Completion (Estimated)
August 31, 2032
Study Completion (Estimated)
August 31, 2032
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.