We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05215561
Recruitment Status : Recruiting
First Posted : January 31, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment
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.

Layout table for study information
Study Type : Observational
Estimated 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 : February 14, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024


Group/Cohort 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.




Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: 52 weeks ]
    Incidence of SAEs will be collected


Secondary Outcome Measures :
  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.

    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.

  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 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).

  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 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).

  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 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.

  8. Incidence of adverse events and adverse drug reactions [ Time Frame: 52 weeks ]
    Incidence of AEs and ADRs will be 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients who received Cosentyx
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05215561


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals +81337978748 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Layout table for location information
Japan
Novartis Investigative Site Recruiting
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site Recruiting
Fukuoka city, Fukuoka, Japan, 814 0180
Novartis Investigative Site Recruiting
Kitakyushu-city, Fukuoka, Japan, 807-8556
Novartis Investigative Site Recruiting
Kurume city, Fukuoka, Japan, 830-0011
Novartis Investigative Site Recruiting
Maebashi city, Gunma, Japan, 371 8511
Novartis Investigative Site Recruiting
Sapporo, Hokkaido, Japan, 007-0841
Novartis Investigative Site Recruiting
Sapporo, Hokkaido, Japan, 064-0807
Novartis Investigative Site Recruiting
Mito, Ibaraki, Japan
Novartis Investigative Site Recruiting
Kahoku-gun, Ishikawa, Japan, 920-0293
Novartis Investigative Site Recruiting
Kamigyo-ku, Kyoto, Japan, 602-8026
Novartis Investigative Site Recruiting
Kyoto-city, Kyoto, Japan, 602-8566
Novartis Investigative Site Recruiting
Sendai city, Miyagi, Japan, 983 8512
Novartis Investigative Site Recruiting
Miyazaki-city, Miyazaki, Japan, 889-1692
Novartis Investigative Site Recruiting
Ikoma, Nara, Japan, 630-0293
Novartis Investigative Site Recruiting
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site Recruiting
Osaka Sayama, Osaka, Japan, 589 8511
Novartis Investigative Site Recruiting
Sakai-city, Osaka, Japan, 591 8025
Novartis Investigative Site Recruiting
Takatsuki-city, Osaka, Japan, 569-8686
Novartis Investigative Site Recruiting
Chuo ku, Tokyo, Japan, 104-8560
Novartis Investigative Site Recruiting
Itabashi ku, Tokyo, Japan, 173 8606
Novartis Investigative Site Recruiting
Minato-ku, Tokyo, Japan, 105-8471
Novartis Investigative Site Recruiting
Shinagawa-ku, Tokyo, Japan, 142-8666
Novartis Investigative Site Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Novartis Investigative Site Recruiting
Sumida-ku, Tokyo, Japan, 130-8587
Novartis Investigative Site Recruiting
Akita, Japan, 010-8543
Novartis Investigative Site Recruiting
Kyoto, Japan, 616-8313
Novartis Investigative Site Recruiting
Miyazaki, Japan, 880-0015
Novartis Investigative Site Recruiting
Wakayama, Japan, 641-0051
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05215561    
Other Study ID Numbers: CAIN457L1401
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
psoriasis vulgaris
psoriatic arthritis
pustular psoriasis
NIS
Japan
Cosentyx
pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases