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Идёт набор NCT07543419

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

— Наблюдательное Hidradenitis Suppurativa

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hidradenitis Suppurativa. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long Term Observational, Prospective, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Within the Italian Population (ANIMA - Italy)

Обзор

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.

Первичные конечные точки

  • Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period. [Срок оценки: Baseline,6 months and 1 and 1,5 years after initiation of secukinumab]
Вторичные конечные точки (12)
  • Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing [Срок оценки: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100) [Срок оценки: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75) [Срок оценки: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Number, type, and localization of HS lesions [Срок оценки: baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Change of total abscess and inflammatory nodule count [Срок оценки: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Proportion of patients receiving up-titration [Срок оценки: Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Proportion of patients receiving down-titration [Срок оценки: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Time to up-titration and down-titration [Срок оценки: Up to 1.5 years]
  • Proportion of patients switching from q4w to q2w treatment [Срок оценки: 6 months and 1.5 years after initiation of secukinumab treatment]
  • Proportion of patients who receive more than one up- and/or down-titration [Срок оценки: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
  • Demographics of adult patients with moderate or severe HS [Срок оценки: Baseline]
  • Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score. [Срок оценки: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]

Критерии участия

Критерии включения

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 ≥ 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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 16 центров
  • Novartis Investigative Site — Ancona
  • Novartis Investigative Site — Bari
  • Novartis Investigative Site — Brescia
  • Novartis Investigative Site — Cona
  • Novartis Investigative Site — Florence
  • Novartis Investigative Site — Genova
  • Novartis Investigative Site — Lecce
  • Novartis Investigative Site — Messina
  • … и ещё 8 центров

Идентификаторы

NCT: NCT07543419 · CAIN457MIT03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗