Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
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Volunteers
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.
Trial design
36 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Novartis Pharmaceuticals; Novartis Pharmaceuticals
Data sourced from clinicaltrials.gov
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