RecruitingNCT06517732

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

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

300 participants

Start Date

Jul 26, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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.

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Interventions

OTHERSecukinumab

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


Locations(20)

Novartis Investigative Site

Izhevsk, Russia

Novartis Investigative Site

Kaliningrad, Russia

Novartis Investigative Site

Kaliningrad, Russia

Novartis Investigative Site

Kazan', Russia

Novartis Investigative Site

Kemerovo, Russia

Novartis Investigative Site

Krasnodar, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Nizhny Novgorod, Russia

Novartis Investigative Site

Penza, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Samara, Russia

Novartis Investigative Site

Saratov, Russia

Novartis Investigative Site

Stavropol, Russia

Novartis Investigative Site

Tula, Russia

Novartis Investigative Site

Ufa, Russia

Novartis Investigative Site

Yakutsk, Russia

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NCT06517732


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