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

NCT06517732 | Active Not Recruiting

• 1 other identifier: CAIN457MRU01
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 19

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).

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; HS; real-world data; secukinumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

  12 months

• Time of initiation of concomitant medication

  12 months

• 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

Study Arms (1)

Secukinumab

Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa

Other: Secukinumab

Interventions

Secukinumab OTHER

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

Secukinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Izhevsk, 426039, Russia

Location

Novartis Investigative Site

Kaliningrad, 236016, Russia

Location

Novartis Investigative Site

Kaliningrad, 236029, Russia

Location

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Kemerovo, 650025, Russia

Location

Novartis Investigative Site

Krasnodar, 350020, Russia

Location

Novartis Investigative Site

Moscow, 107076, Russia

Location

Novartis Investigative Site

Moscow, 119881, Russia

Location

Novartis Investigative Site

Moscow, 123182, Russia

Location

Novartis Investigative Site

Moscow, 129110, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603950, Russia

Location

Novartis Investigative Site

Penza, 440052, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197022, Russia

Location

Novartis Investigative Site

Samara, 443079, Russia

Location

Novartis Investigative Site

Saratov, 410028, Russia

Location

Novartis Investigative Site

Stavropol, 355020, Russia

Location

Novartis Investigative Site

Tula, 300053, Russia

Location

Novartis Investigative Site

Ufa, 450010, Russia

Location

Novartis Investigative Site

Yakutsk, 677000, Russia

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (19)