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

NCT ID: NCT06517732

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-26

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Hidradenitis Suppurativa

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Secukinumab

Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa

Secukinumab

Intervention Type OTHER

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

Interventions

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Secukinumab

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Izhevsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kaliningrad, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kaliningrad, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kazan', , Russia

Site Status RECRUITING

Novartis Investigative Site

Kemerovo, , Russia

Site Status RECRUITING

Novartis Investigative Site

Krasnodar, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status WITHDRAWN

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Nizhny Novgorod, , Russia

Site Status RECRUITING

Novartis Investigative Site

Penza, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Samara, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saratov, , Russia

Site Status RECRUITING

Novartis Investigative Site

Stavropol, , Russia

Site Status RECRUITING

Novartis Investigative Site

Tula, , Russia

Site Status RECRUITING

Novartis Investigative Site

Ufa, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yakutsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CAIN457MRU01

Identifier Type: -

Identifier Source: org_study_id

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