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Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.
This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Pediatric patients with moderate-to-severe plaque psoriasis receiving secukinumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Other | There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug survival rate of secukinumab | Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF). | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secukinumab survival rates | Secukinumab survival rate is defined as proportion of patients who have not discontinued treatment due to reasons other than lack of efficacy. | Week 24, week 52, and week 104 after the index date |
| Time to treatment discontinuation due to ineffectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients aged ≥6 to <18 years old with moderate-to-severe plaque psoriasis after failure/intolerance of frontline treatment in routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chelyabinsk | 454048 | Russia | |||
| Novartis Investigative Site |
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Time from index date to treatment discontinuation due to ineffectiveness |
| Week 12, week 24, week 52, week 104 |
| Proportion of patients achieving PASI 75 responses | Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline. | Baseline (study inclusion), week 24, week 52, and week 104 after the index date |
| Proportion of patients achieving PASI 90 responses | Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline. | Baseline (study inclusion), week 24, week 52, and week 104 after the index date |
| Proportion of patients achieving PASI 100 responses | Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0). | Baseline (study inclusion), week 24, week 52, and week 104 after the index date |
| Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response | Proportion of patients achieving a physicians' global assessment 0/1 response: clear/almost clear skin | Baseline (study inclusion), week 24, week 52, and week 104 after the index date |
| Adverse events (AEs) of special interest | Adverse events (AEs) of special interest: Inflammatory Bowel Disease, malignancy, tuberculosis, serious infections, candidiasis, acute injection site reaction, immunogenicity | Week 12, week 24, week 52, week 104 after the index date |
| Proportion of patients discontinued secukinumab by reason | Proportion of patients discontinued secukinumab by reason:
| Week 12, week 24, week 52 and week 104 |
| Drug survival rate | Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF). | 104 weeks |
| Grozny |
| 364022 |
| Russia |
| Novartis Investigative Site | Izhevsk | 426009 | Russia |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Kemerovo | 650025 | Russia |
| Novartis Investigative Site | Moscow | 105007 | Russia |
| Novartis Investigative Site | Moscow | 117513 | Russia |
| Novartis Investigative Site | Moscow | 119296 | Russia |
| Novartis Investigative Site | Moscow | 119435 | Russia |
| Novartis Investigative Site | Mytishchi | 141009 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | 603950 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344022 | Russia |
| Novartis Investigative Site | Tolyatti | 445846 | Russia |
| Novartis Investigative Site | Tula | 300053 | Russia |
| Novartis Investigative Site | Ufa | 450000 | Russia |
| Novartis Investigative Site | Yakutsk | 677000 | Russia |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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