Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Psoriasis Vulgaris

Psoriatic Arthritis

Eligibility:

All Genders

Up to 17 years

Brief Summary

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 o...

Detailed 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 ad...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

February 14 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 28 2024

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT05215561

Start Date

February 14 2022

End Date

September 28 2024

Last Update

June 8 2025

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Novartis Investigative Site

Nagoya, Aichi-ken, Japan, 467-8602

2

Novartis Investigative Site

Fukuoka, Fukuoka, Japan, 814 0180

3

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan, 807-8556

4

Novartis Investigative Site

Obihiro, Hokkaido, Japan, 080 0013