Prospective, Observational, 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) in Routine Clinical Practice in the Russian Federation (ANIMA-R)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 107
- Locations
- 19
- Primary Endpoint
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
Study Overview
Brief 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).
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who provide written informed consent form (ICF) to participate in the study.
- •Male and female.
- •≥ 18 years old.
- •Diagnosis of moderate or severe HS (Hurley stage and IHS4).
- •Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
- •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
- •Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
- •Participation in an ongoing clinical trial.
- •Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- •Clinically significant infection exacerbation, including active tuberculosis.
- •Patients with active inflammatory bowel disease (IBD).
- •Age <18 years.
- •Pregnancy and breastfeeding.
- •Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
Arms & Interventions
Secukinumab
Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa
Intervention: Secukinumab (Other)
Outcomes
Primary Outcomes
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
Time Frame: 12 months
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.
Secondary Outcomes
- Time of initiation of concomitant medication(12 months)
- Duration of discontinuation/pause of secukinumab treatment before surgery(12 months)
- Duration of discontinuation/pause of secukinumab treatment after surgery(12 months)
- Surgery outcome(12 months)
- Lesion spread(Baseline, month 6, month 12)
- Duration of treatment with concomitant medication(12 months)
- Number, type, and outcome of surgical interventions(12 months)
- Timepoint of and reason for surgical intervention(12 months)
- Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab(12 months)
- Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)(Month 6, month 12)
- Mean change of nodule count(Month 6, month 12)
- Outcome of surgery and adverse events stratified by secukinumab management(12 months)
- Predictors of treatment response(12 months)