Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

Launched by NOVARTIS PHARMACEUTICALS · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a treatment called secukinumab works for adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and abscesses. The study will follow patients over two years to see how doctors adjust the dosage of secukinumab based on individual needs in a real-life setting. This is not a traditional trial with a placebo; instead, it observes how patients respond to the treatment as they receive it in their usual healthcare routine.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of moderate to severe HS. You should also be planning to start treatment with secukinumab, which is a medication that helps reduce inflammation. However, certain health conditions or previous treatments might make you ineligible, so it’s important to discuss your situation with your doctor. Throughout the study, participants will be monitored closely to gather valuable information about the treatment's effectiveness and its impact on daily life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:
• • 1. Patients who provide written informed consent to participate in the study
• • 2. Male and female patients with ≥18 years of age
• • 3. Diagnosis of clinically unequivocal moderate to severe HS
• • 4. Patients for whom a therapy with secukinumab is medically indicated
• • 5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
• • 6. Treatment with secukinumab according to the latest version of SmPC
• • 7. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit
• Exclusion Criteria:
• Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:
• • 1. Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
• • 2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
• • 3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
• • 4. Previous exposure to IL-17 inhibitors
• • 5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors