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

Launched by NOVARTIS PHARMACEUTICALS · Jul 18, 2024

Keywords

ClinConnect Summary

The ANIMA-R study is looking at how effective a medication called secukinumab is for treating adults with moderate to severe Hidradenitis Suppurativa (HS), a skin condition that causes painful lumps and sores. This trial is being conducted in multiple centers across Russia and is currently recruiting participants. To join, you need to be at least 18 years old, have been diagnosed with HS, and have started treatment with secukinumab within the last four weeks. It’s important that the decision to use this medication was made by your doctor based on standard medical practices.

If you decide to participate, you will be observed in a real-world setting, meaning your treatment and its effects will be monitored as part of your regular medical care. However, there are some things that might prevent you from joining, such as having certain medical conditions, being pregnant, or if you've recently received a vaccine. This study aims to gather valuable information about how well secukinumab works for patients like you in everyday situations, helping to improve future treatments for HS.

Gender

ALL

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.