A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China

Novartis

Status

Active, not recruiting

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Treatments

Other: Cosentyx

Study type

Observational

Funder types

Industry

Identifiers

NCT05388916

CAIN457A2406

Details and patient eligibility

About

This is 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 psoriasis treated with Cosentyx® for up to 52 weeks.

Full description

Patients who are about to initiate Cosentyx® or have started Cosentyx® within the last 4 weeks and meet the eligibility criteria will be enrolled. Patients will be followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) will be collected at each visit. No additional study visits, examinations, laboratory tests or procedures will be mandated throughout the study.

Enrollment

42 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.