Status:
COMPLETED
A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate to Severe Chronic Plaque Psoriasis
Eligibility:
All Genders
6-18 years
Brief Summary
This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasi...
Detailed Description
Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinica...
Eligibility Criteria
Inclusion
- Patients meeting all of the following criteria are eligible for inclusion in this study:
- Written assent and informed consent must be obtained as per local regulations prior to any study procedures.
- Diagnosed with moderate to severe plaque psoriasis.
- Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study.
- Aged 6 to less than 18 years at the time they are prescribed Cosentyx®.
- Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®.
Exclusion
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- Patients previously treated with other biologics.
- Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer.
- Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.
Key Trial Info
Start Date :
September 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05388916
Start Date
September 8 2022
End Date
February 27 2025
Last Update
December 29 2025
Active Locations (7)
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1
Novartis Investigative Site
Guangzhou, Guangdong, China, 510091
2
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
3
Novartis Investigative Site
Zhengzhou, Henan, China, 450018
4
Novartis Investigative Site
Shenyang, Liaoning, China, 110004