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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05215561

Collaborator

(none)

Enrollment

Locations

31.5

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris Psoriatic Arthritis Pustular Psoriasis	Other: Cosentyx

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 14, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cosentyx Cosentyx for Subcutaneous Injection	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.

Arm

Intervention/Treatment

Cosentyx

Cosentyx for Subcutaneous Injection

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.

Outcome Measures

Primary Outcome Measures

Incidence of serious adverse events [52 weeks]
Incidence of SAEs will be collected

Secondary Outcome Measures

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. - Normal to pink lesions, no thickening, focal scaling absent or minimal - Pink to pale red lesions, minimal to mild thickening, and mainly fine scaling. - Clearly distinguishable erythema of dull red to bright red, clearly distinguishable to moderate thickening, moderate scaling. - Light red to dark red lesions, high thickness with hard margins, high/rough scaling covering almost all or all lesions.
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.
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 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).
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.
Incidence of adverse events and adverse drug reactions [52 weeks]
Incidence of AEs and ADRs will be collected
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Nagoya-city	Aichi	Japan	467-8602
2	Novartis Investigative Site	Fukuoka city	Fukuoka	Japan	814 0180
3	Novartis Investigative Site	Kitakyushu-city	Fukuoka	Japan	807-8556
4	Novartis Investigative Site	Kurume city	Fukuoka	Japan	830-0011
5	Novartis Investigative Site	Maebashi city	Gunma	Japan	371 8511
6	Novartis Investigative Site	Sapporo	Hokkaido	Japan	007-0841
7	Novartis Investigative Site	Sapporo	Hokkaido	Japan	064-0807
8	Novartis Investigative Site	Mito	Ibaraki	Japan
9	Novartis Investigative Site	Kahoku-gun	Ishikawa	Japan	920-0293
10	Novartis Investigative Site	Kyoto-city	Kyoto	Japan	602-8566
11	Novartis Investigative Site	Sendai city	Miyagi	Japan	983 8512
12	Novartis Investigative Site	Ikoma	Nara	Japan	630-0293
13	Novartis Investigative Site	Okayama-city	Okayama	Japan	700-8558
14	Novartis Investigative Site	Osaka Sayama	Osaka	Japan	589 8511
15	Novartis Investigative Site	Sakai-city	Osaka	Japan	591 8025
16	Novartis Investigative Site	Takatsuki-city	Osaka	Japan	569-8686
17	Novartis Investigative Site	Chuo ku	Tokyo	Japan	104-8560
18	Novartis Investigative Site	Itabashi ku	Tokyo	Japan	173 8606
19	Novartis Investigative Site	Minato-ku	Tokyo	Japan	105-8471
20	Novartis Investigative Site	Shinjuku-ku	Tokyo	Japan	160-0023
21	Novartis Investigative Site	Sumida-ku	Tokyo	Japan	130-8587
22	Novartis Investigative Site	Akita		Japan	010-8543
23	Novartis Investigative Site	Kyoto		Japan	616-8313
24	Novartis Investigative Site	Miyazaki		Japan	880-0015