A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 12 Years and Older With Moderate to Severe Plaque Psoriasis

Study Purpose

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (12 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion 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 within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within 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 within 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 - Participant (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 participant (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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03218488
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag International NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag International NV Clinical Trial
Principal Investigator Affiliation Janssen-Cilag International NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Denmark, France, Germany, Netherlands, Norway, Russian Federation, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants 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 within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within 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 of pediatric participants. 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

Drug: - Ustekinumab

Participants will not receive any intervention as a part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab within clinical practice (patients should either start therapy with ustekinumab within 2 months after the first assessment within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within 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 of pediatric participants.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Uniklinik Graz, Graz, Austria

Status

Not yet recruiting

Address

Uniklinik Graz

Graz, , 8036

UCL Hopital Saint-Luc, Bruxelles, Belgium

Status

Recruiting

Address

UCL Hopital Saint-Luc

Bruxelles, , 1200

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Liege, Belgium

Status

Recruiting

Address

CHU de Liège - Domaine Universitaire du Sart Tilman

Liege, , 4000

Grand Hôpital de Charleroi, Loverval, Belgium

Status

Recruiting

Address

Grand Hôpital de Charleroi

Loverval, , 6280

Bispebjerg Hospital, Copenhagen, Denmark

Status

Recruiting

Address

Bispebjerg Hospital

Copenhagen, , NV 2400

Gentofte Herlev Hospital, Hellerup, Denmark

Status

Recruiting

Address

Gentofte Herlev Hospital

Hellerup, , 2800

Odense Universitetshospital, Odense C, Denmark

Status

Withdrawn

Address

Odense Universitetshospital

Odense C, , 5000

CH Victor Dupouy Argenteuil, Argenteuil, France

Status

Recruiting

Address

CH Victor Dupouy Argenteuil

Argenteuil, , 95107

CHRU Besançon -Hôpital Jean Minjoz, Besançon Cedex, France

Status

Recruiting

Address

CHRU Besançon -Hôpital Jean Minjoz

Besançon Cedex, , 25030

Bordeaux, France

Status

Recruiting

Address

Groupe Hospitalier Pellegrin CHU de Bordeaux

Bordeaux, , 33076

ICH Hopital A. Morvan, Brest Cedex 2, France

Status

Terminated

Address

ICH Hopital A. Morvan

Brest Cedex 2, , 29609

Le Bateau Blanc, Martigues, France

Status

Recruiting

Address

Le Bateau Blanc

Martigues, , 13500

Hôpital Necker Enfants Malades, Paris Cedex 15, France

Status

Recruiting

Address

Hôpital Necker Enfants Malades

Paris Cedex 15, , 75743

CHU Saint-Etienne - Hôpital Nord, Saint-Etienne Cedex 2, France

Status

Recruiting

Address

CHU Saint-Etienne - Hôpital Nord

Saint-Etienne Cedex 2, , 42055

Frankfurt, Germany

Status

Withdrawn

Address

Klinikum der Johann Wolfgang Goethe -Universitaet

Frankfurt, , 60590

Kiel, Germany

Status

Withdrawn

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Praxis Dr. med. Beate Schwarz - Germany, Langenau, Germany

Status

Completed

Address

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , 89129

Gemeinschaftspraxis Dres. Quist, Mainz, Germany

Status

Recruiting

Address

Gemeinschaftspraxis Dres. Quist

Mainz, , 55128

Mainz, Germany

Status

Recruiting

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Radboudumc, Nijmegen, Netherlands

Status

Recruiting

Address

Radboudumc

Nijmegen, , 6525 EX

Oslo, Norway

Status

Recruiting

Address

Oslo universitetssykehus HF, Rikshospitalet

Oslo, , 0027

Moscow, Russian Federation

Status

Recruiting

Address

Moscow Research-Practical Center of Dermatovenerology and Cosmetology

Moscow, , 119049

Moscow, Russian Federation

Status

Recruiting

Address

FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

Moscow, , 119991

Llc Ultramed, Omsk, Russian Federation

Status

Recruiting

Address

Llc Ultramed

Omsk, , 644024

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Saint-Petersburg State Pediatric Medical Academy of RosZdrav

Saint-Petersburg, , 194100

Centre hospitalier universitaire vaudois, Lausanne, Switzerland

Status

Withdrawn

Address

Centre hospitalier universitaire vaudois

Lausanne, , 1011

Kinderspital Zürich, Zürich, Switzerland

Status

Recruiting

Address

Kinderspital Zürich

Zürich, , 8032

University Hospital of Wales, Cardiff, United Kingdom

Status

Recruiting

Address

University Hospital of Wales

Cardiff, , CF14 4XW

Whipps Cross University Hospital, London, United Kingdom

Status

Recruiting

Address

Whipps Cross University Hospital

London, , E11 1NR

Great Ormond Street Hospital, London, United Kingdom

Status

Recruiting

Address

Great Ormond Street Hospital

London, , WC1N 3JH

Salford Royal Hospital, Salford, United Kingdom

Status

Recruiting

Address

Salford Royal Hospital

Salford, , M6 8HD

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