PsoriasisSTELARANCT03218488
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
An observational study of Psoriasis, run by Janssen-Cilag International NV at 30 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ustekinumab
- How many people
- 135 participants
- Where
- 30 sitesin 11 countries
- Study dates
- 25 Oct 2017to 31 Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Is enrolled in an interventional clinical study
Trial locations and contacts
30 sites in 11 countries.
30 sites in 11 countries
France7 sites
CH Victor Dupouy Argenteuil
Argenteuil, 95107
CHRU Besancon Hopital Jean Minjoz
Besançon, 25030
Groupe Hospitalier Pellegrin CHU de Bordeaux
Bordeaux, 33076
ICH Hopital A. Morvan
Brest, 29609
Le Bateau Blanc
Martigues, 13500
Hopital Necker Enfants Malades
Paris, 75743
CHU Saint Etienne Hopital Nord
Saint-Etienne, 42055
Belgium4 sites
UCL Hopital Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Grand Hôpital de Charleroi
Loverval, 6280
Russia4 sites
Moscow Research-Practical Center of Dermatovenerology and Cosmetology
Moscow, 119049
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
Moscow, 119991
Llc Ultramed
Omsk, 644024
Saint-Petersburg State Pediatric Medical Academy of RosZdrav
Saint Petersburg, 194353
United Kingdom4 sites
University Hospital of Wales
Cardiff, CF14 4XW
Whipps Cross University Hospital
London, E11 1NR
Great Ormond Street Hospital
London, WC1N 3JH
Salford Royal Hospital
Salford, M6 8HD
Germany3 sites
Praxis Dr. med. Beate Schwarz - Germany
Langenau, 89129
Gemeinschaftspraxis Dres. Quist
Mainz, 55128
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
Denmark2 sites
Bispebjerg Hospital
Copenhagen, NV 2400
Gentofte Herlev Hospital
Hellerup, 2800
Greece2 sites
Andreas Sygros Hospital
Athens, 16121
University Hospital for Skin and Venereal Diseases
Thessaloniki, 54 643
About this study
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
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).
- Conditions
- Psoriasis
- Being tested
- Ustekinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called STELARA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 50 response represents at least 50 percent improvement from baseline in the PASI score.
Measured: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 75 Response
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 75 response represents at least 75 percent improvement from baseline in the PASI score.
Measured: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 90 Response
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 90 response represents at least 90 percent improvement from baseline in the PASI score.
Measured: 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
The PGA documents the physician's assessment of the severity of the participant's psoriasis lesions at a given time on a 5-point scale, where (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe. Overall lesions are graded for induration, erythema, and scaling. The sum of the 3 scores will be divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.
Measured: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis
Percentage of participant's body surface area covered by plaque-type psoriasis was estimated using the palm method: the area equivalent to the participant's palm extending to the proximal interphalangeal joints and thumb = 1 percent (%) of BSA. The total BSA affected was the summation of the BSA of the individual regions affected.
Measured: Baseline up to end of data collection (maximum of 8 years)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
The Children's Dermatology Quality Life Index (CDLQI) questionnaire is used to assess the participant's perspective on the impact of skin disorders on daily living. It is a 10 item instrument with 4-item response options on a scale from 0 (Not at all) to 3 (Very much) and a recall period of 1 week. The total score ranges from 0 to 30, with lower scores indicating better quality of life.
Measured: Baseline up to end of data collection (maximum of 8 years)
Number of Participants With Comorbidities
Participants are assessed for pre-existing and new comorbidities associated with pediatric plaque psoriasis.
Measured: Baseline up to end of data collection (maximum of 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start25 Oct 2017
- Primary completion31 Aug 2032 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218488
- Sponsor's protocol ID
- CR108277
- Other IDs
- CNTO1275PSO4056
- Acronym
- STELARA
- Status last verified
- Nov 2026
- First submitted
- 13 Jul 2017
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03218488
- Acronym / sponsor ID
- STELARA / CR108277
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 31 Aug 2032 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants 6-17 years of Age With Moderate to Severe Plaque Psoriasis | – | Drug: UstekinumabAll 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). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Is enrolled in an interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: STELARAParticipants 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. | Drug | Participants 6-17 years of Age With Moderate to Severe Plaque Psoriasis |
Primary outcome
Number of Participants With Adverse Events
Time frame: Baseline up to end of data collection ((maximum of 8 years)
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.
Evaluation of Growth: Height
Time frame: Baseline up to end of data collection (maximum of 8 years)
Growth will be based on height recorded at baseline and throughout the observational period.
Evaluation of Growth: Weight
Time frame: Baseline up to end of data collection (maximum of 8 years)
Growth will be based on body weight recorded at baseline and throughout the observational period.
Evaluation of Growth: Body Mass Index (BMI)
Time frame: Baseline up to end of data collection (maximum of 8 years)
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).
Sexual Maturity Based on the Tanner scale
Time frame: Baseline up to end of data collection (maximum of 8 years)
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).
7 secondary outcomes
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response
Time frame: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 75 Response
Time frame: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participants Achieving PASI 90 Response
Time frame: 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
Time frame: Baseline up to end of data collection (maximum of 8 years)
Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis
Time frame: Baseline up to end of data collection (maximum of 8 years)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Time frame: Baseline up to end of data collection (maximum of 8 years)
Number of Participants With Comorbidities
Time frame: Baseline up to end of data collection (maximum of 8 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
30 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen-Cilag International NV at 30 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, Belgium, Russia, United Kingdom, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Baseline up to end of data collection ((maximum of 8 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.