Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis

ClinicalTrials.gov Identifier: NCT05215561

Novartis Reference Number: CAIN457L1401

Last Update: Apr 12, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is a multicenter, centrally registered observational study without a control group. This observational study is a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

Condition

Psoriasis Vulgaris

Psoriatic Arthritis

Pustular Psoriasis

Phase

Not Given

Overall status

Recruiting

Start date

Feb 14, 2022

Completion date

Sep 30, 2024

Gender

All

Age(s)

17 Years and older (Child)

Interventions

Other

Cosentyx

There is no treatment allocation. Patients administered Cosentyx by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
Patients aged less than 18 years at the start of treatment with this drug
Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis

Exclusion Criteria:

Prior treatment with this drug
Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.