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: Sep 07, 2022

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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.

Study Locations

Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 467-8602
Aichi
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 814 0180
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kitakyushu-city, 807-8556
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kurume city, 830-0011
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
Recruiting
Sapporo, 007-0841
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 064-0807
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Mito,
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Kahoku-gun, 920-0293
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Kyoto-city, 602-8566
Kyoto
Japan
Novartis Investigative Site
Recruiting
Sendai city, 983 8512
Miyagi
Japan
Novartis Investigative Site
Recruiting
Miyazaki-city, 889-1692
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Ikoma, 630-0293
Nara
Japan
Novartis Investigative Site
Recruiting
Okayama-city, 700-8558
Okayama
Japan
Novartis Investigative Site
Recruiting
Osaka Sayama, 589 8511
Osaka
Japan
Novartis Investigative Site
Recruiting
Sakai-city, 591 8025
Osaka
Japan
Novartis Investigative Site
Recruiting
Takatsuki-city, 569-8686
Osaka
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Itabashi ku, 173 8606
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato-ku, 105-8471
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160-0023
Tokyo
Japan
Novartis Investigative Site
Recruiting
Sumida-ku, 130-8587
Tokyo
Japan
Novartis Investigative Site
Recruiting
Akita, 010-8543
-
Japan
Novartis Investigative Site
Recruiting
Kyoto, 616-8313
-
Japan
Novartis Investigative Site
Recruiting
Miyazaki, 880-0015
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]