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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
This was a multicenter, centrally registered observational study without a control group. This observational study was 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.
For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF. If a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Obihiro, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Mito, Ibaraki, Japan
Novartis Investigative Site
Kahoku-gun, Ishikawa-ken, Japan
Novartis Investigative Site
Kamigyō-ku, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Start Date
February 14, 2022
Primary Completion Date
September 28, 2024
Completion Date
September 28, 2024
Last Updated
June 8, 2025
36
ACTUAL participants
Cosentyx
OTHER
Lead Sponsor
Novartis Pharmaceuticals
NCT07295509
NCT06100744
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04402086