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: Nov 14, 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.
Interventions
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.
Study Locations
Contacts
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