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

NCT ID: NCT05215561

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis Vulgaris Psoriatic Arthritis Pustular Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cosentyx

Cosentyx for Subcutaneous Injection

Cosentyx

Intervention Type OTHER

There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled.

Interventions

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Cosentyx

There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Obihiro, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Mito, Ibaraki, Japan

Site Status

Novartis Investigative Site

Kahoku-gun, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Kamigyō-ku, Kyoto, Japan

Site Status

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status

Novartis Investigative Site

Ikoma, Nara, Japan

Site Status

Novartis Investigative Site

Moriguchi, Osaka, Japan

Site Status

Novartis Investigative Site

Ōsaka-sayama, Osaka, Japan

Site Status

Novartis Investigative Site

Sakai, Osaka, Japan

Site Status

Novartis Investigative Site

Takatsuki, Osaka, Japan

Site Status

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Sumida-Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Akita, , Japan

Site Status

Novartis Investigative Site

Kyoto, , Japan

Site Status

Novartis Investigative Site

Wakayama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CAIN457L1401

Identifier Type: -

Identifier Source: org_study_id

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