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
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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RECRUITING
300 participants
OBSERVATIONAL
2024-07-26
2026-08-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Secukinumab
Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa
Secukinumab
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CAIN457MRU01
Identifier Type: -
Identifier Source: org_study_id
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