Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

Novartis

Status: Not yet enrolling

Conditions: Pediatric Plaque Psoriasis; Hidradenitis Suppurativa; Juvenile Idiopathic Arthritis

Treatments: Drug: Secukinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07243782

CAIN457MKR01

Details and patient eligibility

About

Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea

Full description

This post-marketing study is a multicenter, single-arm, prospective, observational study.

Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.

Enrollment: 76 estimated patients

Sex: All

Ages: 6 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Hidradenitis suppurativa:

1. Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
2. Patients who have agreed to participate in study (written informed consent)

Pediatric plaque psoriasis:

1. Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
2. Patients with patient or guardian consent to participate in study (written informed consent)

Juvenile idiopathic arthritis:

1. Enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category patients with enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category between the ages of 6 and 18 years and are receiving or will receive Cosentyx within the scope of approved indication.
2. Patients with patient or guardian consent to participate in study (written informed consent)

Exclusion criteria

1. Patients who are contraindicated according to national prescribing information
2. Patients participating in other interventional clinical trials

Trial design

76 participants in 3 patient groups

Secukinumab - HS

Description:

Participants with Hidradenitis Supurativa who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.

Treatment:

Drug: Secukinumab

Secukinumab - Pediatric plaque psoriasis

Description:

Participants with pediatric plaque psoriasis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.

Treatment:

Drug: Secukinumab

Secukinumab - JIA

Description:

Participants with juvenile idiopathic arthritis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.

Treatment:

Drug: Secukinumab