--- title: Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP nct_id: NCT05215561 overall_status: COMPLETED sponsor: Novartis Pharmaceuticals study_type: OBSERVATIONAL primary_condition: Psoriasis Vulgaris countries: Japan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05215561.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05215561" ct_last_update_post_date: 2025-06-08 last_seen_at: "2026-05-12T07:03:13.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP **Official Title:** 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 **NCT ID:** [NCT05215561](https://clinicaltrials.gov/study/NCT05215561) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 36 - **Lead Sponsor:** Novartis Pharmaceuticals - **Conditions:** Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis - **Start Date:** 2022-02-14 - **Completion Date:** 2024-09-28 - **CT.gov Last Update:** 2025-06-08 ## 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. ## 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 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. ## Eligibility - **Minimum age:** 0 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Cosentyx** — Cosentyx for Subcutaneous Injection ## Interventions - **Cosentyx** (OTHER) — There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled. ## Primary Outcomes - **Incidence of serious adverse events** _(time frame: 52 weeks)_ — Incidence of SAEs was collected ## Secondary Outcomes - **Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **All patients: Change from baseline in CDLQI** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Subjects with psoriatic arthritis: Change from baseline in C-HAQ** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Subjects with psoriatic arthritis: Change from baseline in JADAS -27** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Subjects with pustular psoriasis: General improvement in GPP** _(time frame: Baseline, week 4, week 12, week 24 and week 52)_ - **Incidence of adverse events and adverse drug reactions** _(time frame: 52 weeks)_ - **Incidence of adverse events and adverse reactions included in the safety specifications** _(time frame: 52 weeks)_ ## Locations (21) - Novartis Investigative Site, Nagoya, Aichi-ken, Japan - Novartis Investigative Site, Fukuoka, Fukuoka, Japan - Novartis Investigative Site, Kitakyushu, Fukuoka, Japan - Novartis Investigative Site, Obihiro, Hokkaido, Japan - Novartis Investigative Site, Sapporo, Hokkaido, Japan - Novartis Investigative Site, Mito, Ibaraki, Japan - Novartis Investigative Site, Kahoku-gun, Ishikawa-ken, Japan - Novartis Investigative Site, Kamigyō-ku, Kyoto, Japan - Novartis Investigative Site, Kyoto, Kyoto, Japan - Novartis Investigative Site, Sendai, Miyagi, Japan - Novartis Investigative Site, Ikoma, Nara, Japan - Novartis Investigative Site, Moriguchi, Osaka, Japan - Novartis Investigative Site, Ōsaka-sayama, Osaka, Japan - Novartis Investigative Site, Sakai, Osaka, Japan - Novartis Investigative Site, Takatsuki, Osaka, Japan - Novartis Investigative Site, Chuo Ku, Tokyo, Japan - Novartis Investigative Site, Shinjuku Ku, Tokyo, Japan - Novartis Investigative Site, Sumida-Ku, Tokyo, Japan - Novartis Investigative Site, Akita, Japan - Novartis Investigative Site, Kyoto, Japan - Novartis Investigative Site, Wakayama, Japan ## Recent Field Changes (last 30 days) - `results.hasResults` — added _(2026-05-12)_ - `locations.novartis investigative site|nagoya|aichi-ken|japan` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `locations.novartis investigative site|fukuoka|fukuoka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|kitakyushu|fukuoka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|obihiro|hokkaido|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|sapporo|hokkaido|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|mito|ibaraki|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|kahoku-gun|ishikawa-ken|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|kamigyō-ku|kyoto|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|kyoto|kyoto|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|sendai|miyagi|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|ikoma|nara|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|moriguchi|osaka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|ōsaka-sayama|osaka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|sakai|osaka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|takatsuki|osaka|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|chuo ku|tokyo|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|shinjuku ku|tokyo|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|sumida-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|akita||japan` — added _(2026-05-12)_ - `locations.novartis investigative site|kyoto||japan` — added _(2026-05-12)_ - `locations.novartis investigative site|wakayama||japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05215561.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05215561* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*