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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT03218488
• Date of registration: 13/07/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis STELARA
• Scientific 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
• Date of first enrolment: August 29, 2017
• Target sample size: 133
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03218488
• Study type: Observational

Countries of recruitment

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

Contacts

• Name: Study Contact

• Name: Janssen-Cilag International NV Clinical Trial
• Affiliation: Janssen-Cilag International NV

Key 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 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: Ustekinumab

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Evaluation of Growth: Height [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Evaluation of Growth: Body Mass Index (BMI) [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Sexual Maturity Based on the Tanner scale [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Evaluation of Growth: Weight [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Secondary Outcome(s)

Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of 0 or 1 [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Percentage of Participants Achieving PASI 75 Response [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Percentage of Participants Achieving PASI 90 Response [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Number of Participants With Comorbidities [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis [Time Frame: Baseline up to end of data collection (approximately 8 years)]

Secondary ID(s)

CR108277

CNTO1275PSO4056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors