Status:
RECRUITING
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-99 years
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).
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06517732
Start Date
July 26 2024
End Date
August 31 2026
Last Update
December 1 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Izhevsk, Russia, 426039
2
Novartis Investigative Site
Kaliningrad, Russia, 236016
3
Novartis Investigative Site
Kaliningrad, Russia, 236029
4
Novartis Investigative Site
Kazan', Russia, 420012