Study identification

PURI

https://redirect.ema.europa.eu/resource/41293

EU PAS number

EUPAS19506

Study ID

41293

Official title and acronym

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

DARWIN EU® study

No

Study countries

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

Study description

This study aims to monitor the long-term safety, growth and development in pediatric patients (aged 6 years to 18 years) with moderate to severe plaque psoriasis who receive ustekinumab treatment. Primary objective: monitor the long-term safety of ustekinumab in pediatric patients (aged 6 years to 18 years) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity, monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale). Secondary objectives: monitor clinical outcomes (PASI, PGA, and BSA), patient-reported quality of life CDLQI, and comorbidities in pediatric patients with moderate to severe plaque psoriasis treated with ustekinumab.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Ahlem Azzabi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Pharmaceutica NV
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)