Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cosentyx | Cosentyx for Subcutaneous Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events | Incidence of SAEs was collected | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
pediatric patients who received Cosentyx
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, week 4, week 12, week 24 and week 52 |
| 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 |
| 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 |
| 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 |
| Subjects with psoriatic arthritis: Change from baseline in JADAS -27 | 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). | Baseline, week 4, week 12, week 24 and week 52 |
| Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index | 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). | Baseline, week 4, week 12, week 24 and week 52 |
| Subjects with pustular psoriasis: General improvement in GPP | 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. | Baseline, week 4, week 12, week 24 and week 52 |
| Incidence of adverse events and adverse drug reactions | Incidence of AEs and ADRs was collected | 52 weeks |
| 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:
| 52 weeks |
| Fukuoka |
| Fukuoka |
| 814 0180 |
| Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 807-8556 | Japan |
| Novartis Investigative Site | Obihiro | Hokkaido | 080 0013 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 064-0807 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 310-0015 | Japan |
| Novartis Investigative Site | Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| Novartis Investigative Site | Kamigyō-ku | Kyoto | 602-8026 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 983 8512 | Japan |
| Novartis Investigative Site | Ikoma | Nara | 630-0293 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-8507 | Japan |
| Novartis Investigative Site | Ōsaka-sayama | Osaka | 589 8511 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 591 8025 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-8686 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 8560 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Sumida-Ku | Tokyo | 130-8587 | Japan |
| Novartis Investigative Site | Akita | 010-8543 | Japan |
| Novartis Investigative Site | Kyoto | 616-8313 | Japan |
| Novartis Investigative Site | Wakayama | 641-0051 | Japan |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided