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)

Novartis

Status: Enrolling

Conditions: Hidradenitis Suppurativa

Treatments: Other: Secukinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06517732

CAIN457MRU01

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Secukinumab

Description:

Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa

Treatment:

Other: Secukinumab