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) in Routine Clinical Practice in the Russian Federation
NCT Number: NCT06517732
Acronym: ANIMA-R
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hidradenitis Suppurativa
Interventions: OTHER: Secukinumab
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2026-06-28
Locations: Novartis Investigative Site, Moscow, 129110, Russian Federation|Novartis Investigative Site, Nizhny Novgorod, 603066, Russian Federation|Novartis Investigative Site, Tula, 300053, Russian Federation

Summary:
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).

Primary Outcome Measures: Proportion of patients achieving 55% reduction in IHS4 (IHS4-55), The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (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 lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate., 12 months
Secondary Outcome Measures: Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab, Proportion of patients receiving Hidradenitis Suppurativa (HS)-specific concomitant treatments in combination with secukinumab, 12 months|Time of initiation of concomitant medication, Time of initiation of concomitant medication (before or after the initiation of secukinumab)., 12 months|Duration of treatment with concomitant medication, Duration of treatment with concomitant medication of secukinumab, 12 months|Number, type, and outcome of surgical interventions, Number, type, and outcome of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home), 12 months|Timepoint of and reason for surgical intervention, Timepoint of and reason for surgical intervention., 12 months|Duration of discontinuation/pause of secukinumab treatment before surgery, Duration of discontinuation/pause of secukinumab treatment before surgery, 12 months|Duration of discontinuation/pause of secukinumab treatment after surgery, Duration of discontinuation/pause of secukinumab treatment after surgery, 12 months|Surgery outcome, Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab., 12 months|Outcome of surgery and adverse events stratified by secukinumab management, Outcome of surgery (healing, pain relief) and adverse events (i.e., infections) stratified by secukinumab management (continuation or discontinuation)., 12 months|Predictors of treatment response, Listing of predictors of treatment response, 12 months|Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100), The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (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 lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate., Month 6, month 12|Lesion spread, Lesion spread (defined as total abscess and inflammatory nodule count (AN) or draining fistula in a body region not seen at baseline) assessed by number, type, and localization of HS lesions, Baseline, month 6, month 12|Mean change of nodule count, Mean reduction of nodule count, Month 6, month 12