A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

— STELARA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218488
• Other study ID #: CR108277
• Secondary ID: CNTO1275PSO4056
• Status: Recruiting
• Start date: August 29, 2017
• Est. completion date: August 31, 2032

Study information

• Verified date: June 2024
• Source: Janssen-Cilag International NV
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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 information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: August 31, 2032
• Est. primary completion date: August 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Uniklinik Graz	Graz
Belgium	UCL Hopital Saint-Luc	Bruxelles
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège - Domaine Universitaire du Sart Tilman	Liege
Belgium	Grand Hôpital de Charleroi	Loverval
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Gentofte Herlev Hospital	Hellerup
France	CH Victor Dupouy Argenteuil	Argenteuil
France	CHRU Besancon Hopital Jean Minjoz	Besançon Cedex
France	Groupe Hospitalier Pellegrin CHU de Bordeaux	Bordeaux
France	ICH Hopital A. Morvan	Brest Cedex 2
France	Le Bateau Blanc	Martigues
France	Hôpital Necker Enfants Malades	Paris Cedex 15
France	CHU Saint Etienne Hopital Nord	Saint-Etienne Cedex 2
Germany	Praxis Dr. med. Beate Schwarz - Germany	Langenau
Germany	Gemeinschaftspraxis Dres. Quist	Mainz
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Greece	Andreas Sygros Hospital	Athens
Greece	University Hospital for Skin and Venereal Diseases	Thessaloniki
Netherlands	Radboudumc	Nijmegen
Norway	Oslo universitetssykehus HF, Rikshospitalet	Oslo
Russian Federation	FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences	Moscow
Russian Federation	Moscow Research-Practical Center of Dermatovenerology and Cosmetology	Moscow
Russian Federation	Llc Ultramed	Omsk
Russian Federation	Saint-Petersburg State Pediatric Medical Academy of RosZdrav	Sankt-Peterburg
Switzerland	Kinderspital Zürich	Zürich
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	Whipps Cross University Hospital	London
United Kingdom	Salford Royal Hospital	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Greece,  Netherlands,  Norway,  Russian Federation,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (approximately 8 years)
Primary	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 (approximately 8 years)
Primary	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 (approximately 8 years)
Primary	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 (approximately 8 years)
Primary	Sexual Maturity Based on the Tanner scale	The Tanner scale is used to measure visible changes during puberty commonly referred to as "Tanner stages". 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 (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	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.	Baseline up to end of data collection (approximately 8 years)
Secondary	Number of Participants With Comorbidities	Participants are assessed for pre-existing and new comorbidities associated with pediatric plaque psoriasis.	Baseline up to end of data collection (approximately 8 years)