All studies
Active not recruitingOBSERVATIONAL

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.

This study is gathering information on how a medicine called secukinumab is used for adults with moderate to severe hidradenitis suppurativa (HS) in everyday medical practice. Researchers want to observe how doctors prescribe and adjust doses of secukinumab for patients in Germany over a two-year period. This is an "observational" study, meaning patients will receive their usual care with secukinumab as decided by their doctor, and researchers will simply collect data on this treatment. The goal is to understand how secukinumab is used in the real world and what factors doctors consider when deciding on a flexible dosing plan for their patients with HS.

At a glance

Status
Active not recruiting
Sponsor
Novartis Pharmaceuticals
Enrolment target
435
Start
10 Aug 2023
Estimated completion
31 Mar 2027

What is this study about?

Imagine your doctor suggests a treatment for your hidradenitis suppurativa (HS), and you start taking it. This study is simply observing how that treatment works for people like you in everyday clinics, rather than in a highly controlled research setting. It's focused on a specific medicine called secukinumab, which is used for moderate to severe HS in adults.

The main idea is to see how doctors in Germany are using secukinumab with their patients over two years. This includes how often the medicine is given, how the dose might be changed over time, and what reasons doctors have for making those decisions. The study aims to gather a wide range of information from many different dermatology clinics, to get a really good picture of how the medicine is used in the 'real world'.

This kind of study is important because it helps medical experts understand how treatments work outside of strict trial conditions. It gives valuable insights into actual patient care and can help doctors make even better decisions for future patients with HS.

Key takeaways

  • This study observes real-world use of secukinumab for HS.
  • It's for adults with moderate to severe HS who are starting secukinumab.
  • You get your regular HS treatment; the study just collects data.
  • The aim is to understand how doctors use secukinumab and adjust doses.
  • Participation lasts two years and involves sharing your routine medical notes.
  • Your medical care will not be changed by taking part in this study.

Who may be eligible?

To be part of this study, you would need to be an adult (18 years or older) with a clear diagnosis of moderate to severe hidradenitis suppurativa (HS). Importantly, your doctor must have already decided that treatment with secukinumab is the right choice for you, and you would be starting this medicine as part of your usual care, not because of the study itself. You also need to agree in writing to let your medical information be collected for the study.

There are also some reasons why you wouldn't be able to join. For example, if you have certain other health conditions like inflammatory bowel disease (Crohn's disease or ulcerative colitis), or if you're taking part in another research study at the same time, this study wouldn't be suitable for you. Also, if you've already been treated with certain other types of biologic medicines (like IL-17 inhibitors or other biologics if you haven't had them before), you wouldn't be eligible.

Basically, if secukinumab is already medically indicated for your HS and you're about to start it, and you don't have any of the specific conditions mentioned that would prevent you from taking it, then you might be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have moderate to severe hidradenitis suppurativa (HS)?
  3. Has your doctor decided you should start secukinumab for your HS?
  4. Do you NOT have conditions like Crohn's disease or ulcerative colitis?
  5. Are you NOT currently in another research study with secukinumab or similar drugs?
  6. Have you NOT used certain other 'biologic' medicines (like IL-17 inhibitors) before?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be receiving secukinumab as your doctor has prescribed for your hidradenitis suppurativa, just as you would if you weren't in the study. The study doesn't involve any extra or different treatments. Instead, researchers will simply be collecting information about your health and your secukinumab treatment during your regular clinic visits over a two-year period. This means they'll gather details on how your condition is progressing, how often you take your medication, and any changes your doctor makes to your treatment plan. The study simply observes what's already happening with your care.

Potential risks and benefits

Participating in this study means that your medical information related to your secukinumab treatment will be collected and studied, which can help improve understanding of HS care for others. There are no direct medical benefits to you for taking part, as you'll be receiving the same care you would otherwise. Since you're not getting any different treatment, the risks are generally minimal and related to the privacy of your medical data, which will be handled carefully. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (80)

  • Novartis Investigative Site
    Verified postcode
    Freiburg im Breisgau, Germany
  • Novartis Investigative Site
    Verified postcode
    Rheinstetten, Germany
  • Novartis Investigative Site
    Verified postcode
    Haßfurt, Germany
  • Novartis Investigative Site
    Verified postcode
    Kulmbach, Germany
  • Novartis Investigative Site
    Verified postcode
    Lauf an der Pegnitz, Germany
  • Novartis Investigative Site
    Verified postcode
    Nuremberg, Germany
  • Novartis Investigative Site
    City only
    Panketal, Germany
  • Novartis Investigative Site
    Verified postcode
    Hamburg, Germany
  • Novartis Investigative Site
    Verified postcode
    Lingen, Germany
  • Novartis Investigative Site
    Verified postcode
    Bergen auf Rügen, Germany
  • Novartis Investigative Site
    Verified postcode
    Kröpelin, Germany
  • Novartis Investigative Site
    Verified postcode
    Krefeld, Germany

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps and boils, usually in areas where skin rubs together, like the armpits or groin.

What is secukinumab?

Secukinumab is a medicine used to treat certain inflammatory conditions, including moderate to severe HS.

Do I have to take a new medicine if I join?

No, you would only join if your doctor has already decided for you to start secukinumab as part of your usual HS treatment.

Will this study change my usual medical appointments?

No, your medical care and appointments will remain the same. The study just collects information during your regular visits.

How long will I be part of the study?

The study will collect information over a period of two years from when you start your secukinumab treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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