Last Update: Aug 09, 2024
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)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAIN457MRU01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS). 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.

Hidradenitis Suppurativa
Recruiting
300
Jul 26, 2024
Jun 28, 2026
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

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

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.

Novartis Investigative Site

Recruiting

Moscow,129110,Russian Federation

Novartis Investigative Site

Recruiting

Nizhny Novgorod,603066,Russian Federation

Novartis Investigative Site

Recruiting

Tula,300053,Russian Federation

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