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

N/AActive Not RecruitingNCT06517732

Novartis Pharmaceuticals107 enrolled

Overview

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

The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population. The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

Study Type

OBSERVATIONAL

Enrollment

107

Conditions

Hidradenitis Suppurativa

Interventions

SecukinumabOTHER

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who provide written informed consent form (ICF) to participate in the study. 2. Male and female. 3. ≥ 18 years old. 4. Diagnosis of moderate or severe HS (Hurley stage and IHS4). 5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF. 6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation. Exclusion Criteria: 1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making. 2. Participation in an ongoing clinical trial. 3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex). 4. Clinically significant infection exacerbation, including active tuberculosis. 5. Patients with active inflammatory bowel disease (IBD). 6. Age \<18 years. 7. Pregnancy and breastfeeding. 8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.

Locations (19)

Novartis Investigative Site

Izhevsk, Russia

Novartis Investigative Site

Kaliningrad, Russia

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Time of initiation of concomitant medication

Time of initiation of concomitant medication (before or after the initiation of secukinumab).

Time frame: 12 months

Duration of treatment with concomitant medication

Duration of treatment with concomitant medication of secukinumab

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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