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.
Interventions
Secukinumab
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.
Study Location
Novartis Investigative Site
Recruiting
Tula,300053,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,129110,Russian Federation
Novartis Investigative Site
Recruiting
Nizhny Novgorod,603066,Russian Federation
Worldwide Contacts
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