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Completed

NCT Number: NCT05215561

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

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.

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Key information

Conditions

Psoriasis Vulgaris Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Pustular Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Incidence of serious adverse events

    Time frame: 52 weeks

    Incidence of SAEs was collected

Secondary outcomes

  1. 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

    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.

  2. Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response

    Time frame: 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.

  3. All patients: Change from baseline in CDLQI

    Time frame: 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.

  4. Subjects with psoriatic arthritis: Change from baseline in C-HAQ

    Time frame: 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.

  5. Subjects with psoriatic arthritis: Change from baseline in JADAS -27

    Time frame: Baseline, week 4, week 12, week 24 and week 52

    Juvenile Arthritis Disease Activity Score (JADAS) score was used to assess disease activity in patients with juvenile idiopathic arthritis including psoriatic arthritis. The investigator assessed 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).

  6. 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

    The investigator determined 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).

  7. Subjects with pustular psoriasis: General improvement in GPP

    Time frame: Baseline, week 4, week 12, week 24 and week 52

    GPP: Generalized Pustular Psoriasis The investigator assessed 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.

  8. Incidence of adverse events and adverse drug reactions

    Time frame: 52 weeks

    Incidence of AEs and ADRs was collected

  9. Incidence of adverse events and adverse reactions included in the safety specifications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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