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Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe HS Within the Italian Population

Recruitingn/aAges 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on secukinumab, healthcare resource utilization and the economic impact of HS in Italy.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Study participants eligible for inclusion in this study must meet all the following criteria: 1\. Male and Female patients who provide written informed consent and privacy form (ICF\&PF) to participate in the study. 2\. Aged โ‰ฅ 18 years at ICF\&PF signature. 3. Patients with moderate or severe HS (IHS4 and/or Hurley staging system, as assessed by the investigators) at index date. 4\. The start of secukinumab is within 30 days after the ICF\&PF signature (enrolment), as per local standard clinical practice. Patients were not treated with secukinumab before enrolment within the Managed Access Program (MAP). The initiation of secukinumab is based on dermatologist's own practice, regardless of study participation. For HRU and economic burden only: 5\. Patients who provide written ICF\&PF to allow the use of secondary (administrative) data for the purposes of this study. 6\. Patients with more than 12 months of residence inside the area of competence of the LHU (applicable only to study sites associated with the 6 LHUs). Exclusion Criteria: Study participants meeting any of the following criteria are not eligible for inclusion in this study: 7\. Participation in an ongoing clinical trial. 8. Any medical or psychological condition that may prevent study participation, based on practitioners' decision-making. For HRU and economic burden only: 9\. Patients will be excluded if the unique identifier does not allow them to be identified in the LHU administrative databases related to the site where they were enrolled.
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What it tests

  • Not listed
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Where

16 sites
Novartis Investigative Site
Ancona, Italy
Novartis Investigative Site
Bari, Italy
Novartis Investigative Site
Brescia, Italy
Novartis Investigative Site
Cona, Italy
Novartis Investigative Site
Florence, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Lecce, Italy
Novartis Investigative Site
Messina, Italy

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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