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

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05215561
• Other study ID #: CAIN457L1401
• Status: Active, not recruiting
• Start date: February 14, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriasis Vulgaris
• Psoriatic Arthritis
• Pustular Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Ikoma	Nara
Japan	Novartis Investigative Site	Kahoku-gun	Ishikawa
Japan	Novartis Investigative Site	Kamigyo-ku	Kyoto
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Mito	Ibaraki
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Obihiro	Hokkaido
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Sakai-city	Osaka
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Sumida-ku	Tokyo
Japan	Novartis Investigative Site	Takatsuki-city	Osaka
Japan	Novartis Investigative Site	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events	Incidence of SAEs will be collected	52 weeks
Secondary	Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response	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.	Baseline, week 4, week 12, week 24 and week 52
Secondary	Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response	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.	Baseline, week 4, week 12, week 24 and week 52
Secondary	All patients: Change from baseline in CDLQI	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.	Baseline, week 4, week 12, week 24 and week 52
Secondary	Subjects with psoriatic arthritis: Change from baseline in C-HAQ	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.	Baseline, week 4, week 12, week 24 and week 52
Secondary	Subjects with psoriatic arthritis: Change from baseline in JADAS -27	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).	Baseline, week 4, week 12, week 24 and week 52
Secondary	Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index	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).	Baseline, week 4, week 12, week 24 and week 52
Secondary	Subjects with pustular psoriasis: General improvement in GPP	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.	Baseline, week 4, week 12, week 24 and week 52
Secondary	Incidence of adverse events and adverse drug reactions	Incidence of AEs and ADRs will be collected	52 weeks
Secondary	Incidence of adverse events and adverse reactions included in the safety specifications	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	52 weeks