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 Hidradenitis Suppurativa.

Condition(s) studied

Investigational drug(s) / intervention(s)

secukinumab: Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

Study summary

The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

Eligibility

Primary outcome measure(s)

• Proportion of patients receiving up-titration — Up to 24 months
  Proportion of patients receiving up-titration (q4w-to-q2w)
• Proportion of patients receiving down-titration — Up to 24 months
  Proportion of patients receiving down-titration (q2w-to-q4w)
• Time to up-titration and down-titration — Up to 2 years
  Time to up-titration and down-titration
• Duration of q4w treatment with secukinumab after dose reduction — Up to 2 years
  Duration of q4w treatment with secukinumab after dose reduction
• Proportion of patients who receive more than one up-and/or down titration — Up to 24 months
  Proportion of patients who receive more than one up-and/or down titration
• Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab — Up to 2 years
  Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
• Number and type of surgical interventions — Up to 2 years
  Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient
• Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) — Up to 24 months
  The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS
• mean change of International Hidradenitis Suppurativa Severity Score System (IHS4) — Up to 24 months
  The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS
• Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire — Up to 24 months
  The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
• Mean reduction of Abscesses and inflammatory nodules (AN) count — Up to 24 months
  Mean reduction of Abscesses and inflammatory nodules (AN) count
• Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30) — Up to 24 months
  The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). To assess this, the patient should concentrate on the pain that his/her skin lesions generate. The Patient's Global Assessment of Skin Pain - NRS will be completed by the subject electronically via a web-based application or in paper form.

Trial sites (80)

+ 40 more sites — see the full list on the official registry below.

On this site

More Novartis Pharmaceuticals trials in Germany

Other trials for the same condition