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
1 other identifier
observational
36
1 country
21
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2022
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2024
CompletedJune 8, 2025
June 1, 2025
2.6 years
January 19, 2022
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of serious adverse events
Incidence of SAEs was collected
52 weeks
Secondary Outcomes (9)
Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response
Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response
Baseline, week 4, week 12, week 24 and week 52
All patients: Change from baseline in CDLQI
Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in C-HAQ
Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in JADAS -27
Baseline, week 4, week 12, week 24 and week 52
- +4 more secondary outcomes
Study Arms (1)
Cosentyx
Cosentyx for Subcutaneous Injection
Interventions
There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled.
Eligibility Criteria
pediatric patients who received Cosentyx
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with this drug
- Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, 814 0180, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-8556, Japan
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 064-0807, Japan
Novartis Investigative Site
Mito, Ibaraki, 310-0015, Japan
Novartis Investigative Site
Kahoku-gun, Ishikawa-ken, 920-0293, Japan
Novartis Investigative Site
Kamigyō-ku, Kyoto, 602-8026, Japan
Novartis Investigative Site
Kyoto, Kyoto, 602-8566, Japan
Novartis Investigative Site
Sendai, Miyagi, 983 8512, Japan
Novartis Investigative Site
Ikoma, Nara, 630-0293, Japan
Novartis Investigative Site
Moriguchi, Osaka, 570-8507, Japan
Novartis Investigative Site
Ōsaka-sayama, Osaka, 589 8511, Japan
Novartis Investigative Site
Sakai, Osaka, 591 8025, Japan
Novartis Investigative Site
Takatsuki, Osaka, 569-8686, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 104 8560, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0023, Japan
Novartis Investigative Site
Sumida-Ku, Tokyo, 130-8587, Japan
Novartis Investigative Site
Akita, 010-8543, Japan
Novartis Investigative Site
Kyoto, 616-8313, Japan
Novartis Investigative Site
Wakayama, 641-0051, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2022
First Posted
January 31, 2022
Study Start
February 14, 2022
Primary Completion
September 28, 2024
Study Completion
September 28, 2024
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share