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

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Hidradenitis Suppurativa

Scalp Disorders

Treatment

Secukinumab

Clinical Study ID

NCT06517732
CAIN457MRU01
  • Ages 18-99
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who provide written informed consent form (ICF) to participate in thestudy.

  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 towritten ICF.

  6. Decision for secukinumab prescription was made by the attending physician accordingto the approved national label during routine clinical practice, regardless of studyparticipation.

Exclusion

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.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase:
Study Start date:
July 26, 2024
Estimated Completion Date:
June 28, 2026

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Izhevsk, 426039
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kazan, 420012
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kemerovo, 650025
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Moscow, 119049
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nizhniy Novgorod, 603950
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nizhny Novgorod, 603066
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 197022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Samara, 443079
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Stavropol, 355020
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tula, 300053
    Russian Federation

    Active - Recruiting

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