Clinical trial NCT03218488: A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 135
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Evaluation of Growth: Height
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Evaluation of Growth: Weight
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Evaluation of Growth: Body Mass Index (BMI)
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Sexual Maturity Based on the Tanner scale
timeFrame: Baseline up to end of data collection (approximately 8 years)
Secondary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Percentage of Participants Achieving PASI 75 Response
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Percentage of Participants Achieving PASI 90 Response
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of 0 or 1
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
timeFrame: Baseline up to end of data collection (approximately 8 years)
measure: Number of Participants With Comorbidities
timeFrame: Baseline up to end of data collection (approximately 8 years)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Uniklinik Graz
city: Bruxelles
country: Belgium
facility: UCL Hopital Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Loverval
country: Belgium
facility: Grand Hôpital de Charleroi
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Herlev Hospital
city: Argenteuil
country: France
facility: CH Victor Dupouy Argenteuil
city: Besancon Cedex
country: France
facility: CHRU Besancon Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin CHU de Bordeaux
city: Brest Cedex 2
country: France
facility: ICH Hopital A. Morvan
city: Martigues
country: France
facility: Le Bateau Blanc
city: Paris Cedex 15
country: France
facility: Hopital Necker Enfants Malades
city: Saint-Etienne Cedex 2
country: France
facility: CHU Saint Etienne Hopital Nord
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Mainz
country: Germany
facility: Gemeinschaftspraxis Dres. Quist
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Athens
country: Greece
facility: Andreas Sygros Hospital
city: Thessaloniki
country: Greece
facility: University Hospital for Skin and Venereal Diseases
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF, Rikshospitalet
city: Moscow
country: Russian Federation
facility: Moscow Research-Practical Center of Dermatovenerology and Cosmetology
city: Moscow
country: Russian Federation
facility: FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
city: Omsk
country: Russian Federation
facility: Llc Ultramed
city: Sankt-Peterburg
country: Russian Federation
facility: Saint-Petersburg State Pediatric Medical Academy of RosZdrav
city: Zürich
country: Switzerland
facility: Kinderspital Zürich
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: