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

Completed

• Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular Psoriasis
• Interventions: Other: Cosentyx

• Registration Number: NCT05215561
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

For patients who discontinued or completed this drug before the end of the observation period, the investigator will record 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 withdraws consent, information will be collected during the observation period up to the date of consent withdrawal.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-31
• Study Start: 2022-02-14
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cosentyx	Cosentyx	Cosentyx for Subcutaneous Injection

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events	52 weeks	Incidence of SAEs will be collected

Secondary Outcome Measures

Name	Time	Method
Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response	Baseline, week 4, week 12, week 24 and week 52	Psoriasis Area and Severity Index (PASI) 75/90 response is defined as ≥ 75%, ≥ 90% improvement (reduction) in PASI score compared to Baseline.; PASI 100 response means no sign of body psoriasis.
All patients: Change from baseline in CDLQI	Baseline, week 4, week 12, week 24 and week 52	Children's Dermatology Life Quality Index (CDLQI) is a global dermatology disability index designed to assess health-related quality of life in pediatric patients and consists of 10 questions about symptoms and feelings, leisure, school and holidays, personal relationships, sleep, and treatment. The total CDLQI score is the sum of 10 questions and ranges from 0 \~ 30. Higher scores indicate more impairment of health-related quality of life.
Incidence of adverse events and adverse drug reactions	52 weeks	Incidence of AEs and ADRs will be collected
Subjects with psoriatic arthritis: Change from baseline in C-HAQ	Baseline, week 4, week 12, week 24 and week 52	Childhood Health Assessment Questionnaire (C-HAQ) is used to assess the QOL of patients with psoriatic arthritis.; The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Higher scores mean worse quality of life.
Subjects with pustular psoriasis: General improvement in GPP	Baseline, week 4, week 12, week 24 and week 52	GPP: Generalized Pustular Psoriasis The investigator will assess the General improvement rating (Responder, partial-responder, non-responder, aggravated, indeterminate) of pustular psoriasis symptoms at each observation time point compared to the start of treatment with this drug.
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	Investigator's Global Assessment (IGA) rating scale is: 0 - no signs of psoriasis. Postinflammatory hyperpigmentation may be present.; 1. - Normal to pink lesions, no thickening, focal scaling absent or minimal; 2. - Pink to pale red lesions, minimal to mild thickening, and mainly fine scaling.; 3. - Clearly distinguishable erythema of dull red to bright red, clearly distinguishable to moderate thickening, moderate scaling.; 4. - Light red to dark red lesions, high thickness with hard margins, high/rough scaling covering almost all or all lesions.
Subjects with psoriatic arthritis: Change from baseline in JADAS -27	Baseline, week 4, week 12, week 24 and week 52	Juvenile Arthritis Disease Activity Score (JADAS) score will be used to assess disease activity in patients with juvenile idiopathic arthritis including psoriatic arthritis. The investigator will assess each of the 4 components of the JADAS for patients with psoriatic arthritis (Rater's Global Assessment, Patient's or guardian's global assessment, Number of active arthritis and CRP) and record the results in the CRF. JADAS-27 is the sum of the 4 scores (0 \~ 57).
Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index	Baseline, week 4, week 12, week 24 and week 52	The investigator will determine the severity based on the areas of erythema with pustules, areas of erythema (total), areas of edema, fever, WBC count, CRP, and serum albumin. The total score in the severity index is divided into 0 \~ 17 points (1 \~ 6 = mild, 7 \~ 10 = moderate, 11 \~ 17 = severe).
Incidence of adverse events and adverse reactions included in the safety specifications	52 weeks	Important identified risks or important potential risks specified in the Risk Management Plan at the time of planning the surveillance were determined to be identified in the surveillance. The following items were set as the safety specifications for the surveillance: * Serious infections; * Neutrophil count decreased; * Hypersensitivity Reactions; * inflammatory bowel disease; * Erythroderma (exfoliative dermatitis); * Malignancies; * Cardiovascular/cerebrovascular events; * Tuberculosis; * Events related to suicide/self-injury

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Wakayama, Japan