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This was a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.
Patients who were about to initiate Cosentyx® or had started Cosentyx® within the last 4 weeks and met the eligibility criteria were enrolled. Patients were followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) were collected at each visit. No additional study visits, examinations, laboratory tests or procedures were mandated throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cosentyx | Pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosentyx | Other | Prospective observational cohort study. There was treatment allocation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs/SAEs/AESIs type and frequency | Adverse events (AEs)/ Serious adverse events (SAEs)/Adverse events of special interest (AESIs). | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who achieved PASI 75 response | Percentage of participants who achieve 75% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4). |
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Inclusion Criteria:
Patients meeting all of the following criteria are eligible for inclusion in this study:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for inclusion in this study:
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Chinese pediatric patients aged between 6 to less than 18 years and diagnosed with moderate to severe plaque psoriasis.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Guangzhou | Guangdong | 510091 | China | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Week 12 |
| Percentage of patients who achieved IGA mod 2011 0 or 1 response | The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Week 12 |
| Percentage of patients who achieved PASI 90/100 response | Percentage of participants who achieve 90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4). | Week 12 |
| Percentage of patients who achieved PASI 75/90/100 response/IGA mod 2011 0 or 1 response over time | Percentage of participants who achieve 75/90/100% reduction in the Psoriasis Area and Severity Index (PASI) score compared to baseline. A PASI score is a tool used to measure the severity and extent of psoriasis. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and is not compared with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Up to week 52 |
| Absolute value change from baseline of PASI score over time | Psoriasis Area and Severity Index (PASI) score s a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4). | Up to week 52 |
| Absolute value change from baseline of IGA mod 2011 score over time | The Investigator's Global Assessment (IGA) mod 2011 scale scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Up to week 52 |
| Shijiazhuang |
| Hebei |
| 050000 |
| China |
| Novartis Investigative Site | Zhengzhou | Henan | 450018 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110004 | China |
| Novartis Investigative Site | Xian | Shanxi | 710004 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310009 | China |
| Novartis Investigative Site | Beijing | 100069 | China |