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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Primary outcome measures
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period. [Time frame: Baseline,6 months and 1 and 1,5 years after initiation of secukinumab]
Secondary outcome measures (12)
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing [Time frame: 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) [Time frame: 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) [Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Number, type, and localization of HS lesions [Time frame: baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Change of total abscess and inflammatory nodule count [Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Proportion of patients receiving up-titration [Time frame: Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Proportion of patients receiving down-titration [Time frame: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Time to up-titration and down-titration [Time frame: Up to 1.5 years]
- Proportion of patients switching from q4w to q2w treatment [Time frame: 6 months and 1.5 years after initiation of secukinumab treatment]
- Proportion of patients who receive more than one up- and/or down-titration [Time frame: within 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
- Demographics of adult patients with moderate or severe HS [Time frame: Baseline]
- Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score. [Time frame: 6 months, 1 and 1.5 years after initiation of secukinumab treatment]
Eligibility criteria
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 ≥ 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 16 centers
- 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
- … and 8 more centers
Identifiers
NCT: NCT07543419 · CAIN457MIT03