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AutorisiertTherapeutische Anwendung (Phase IV)Interventionell

IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.

This research is specifically for individuals in the UK living with psoriatic arthritis who haven't found enough relief from standard treatments. The study aims to understand how a medication called Taltz (active ingredient ixekizumab) works in these patients. Doctors want to discover specific signs in the body, called biomarkers, that can help predict if Taltz will be an effective treatment. By identifying these biomarkers, the hope is to personalise treatment in the future, ensuring patients receive the most helpful medicine sooner. This is a "Phase IV" study, meaning Taltz is already approved for use, and this research helps us learn more about it in real-world settings.

Auf einen Blick

Status
Autorisiert
Phase
Therapeutische Anwendung (Phase IV)
Sponsor
University Hospital Of Ferrara
Einschreibeziel
30
Starten
24 Jun 2025

Worum geht es in dieser Studie?

This study, called "PRECISE," is looking into a medicine called Taltz for people with a type of arthritis called psoriatic arthritis. This condition causes joint pain, swelling, and stiffness, often alongside a skin condition called psoriasis. Sometimes, standard treatments don't work well enough for everyone, and their symptoms continue to be troublesome.

The main goal of this study is to find out if there are specific clues in the body, known as "biomarkers," that can tell us who will respond best to Taltz. Think of biomarkers as internal signals or indicators. By understanding these signals, doctors hope to predict which patients are most likely to benefit from Taltz, helping to get the right treatment to the right person more quickly in the future. They will also be closely monitoring how well Taltz improves patients' symptoms.

Taltz is a medicine that's already approved and available, so this study is about learning more about how it works and who it helps most in a real-world setting. Researchers will be checking if patients feel better, if their joints improve, and if certain measurements show a positive change after taking Taltz for a period of time.

Wichtige Erkenntnisse

  • Targets psoriatic arthritis that hasn't responded to other treatments.
  • Investigates the medicine Taltz (ixekizumab).
  • Aims to find body signals (biomarkers) to predict treatment success.
  • May help personalise treatment for psoriatic arthritis in the future.
  • Research is happening in the UK.
  • This is a study for an already approved medicine to learn more about its effects.

Wer könnte berechtigt sein?

To be part of this study, you need to be an adult, 18 years or older, and can be male or female. You must have psoriatic arthritis that hasn't responded well enough to other treatments you've tried.

The research team will need to check your medical history and do some tests to make sure the study is a safe and suitable option for you. They will look at specific details about your psoriatic arthritis and any other health conditions you might have.

It's important to remember that not everyone with psoriatic arthritis will be able to join. The researchers have specific requirements to ensure the study produces clear and useful results and that participants are kept safe.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Sind Sie 18 Jahre alt oder älter?
  2. Do you have psoriatic arthritis?
  3. Has your psoriatic arthritis not responded well to previous treatments?
  4. Are you able to attend regular study appointments?
  5. Are you able to consider injection-based medication?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you decide to take part in this study, you would receive the study medication, Taltz (80 mg solution for injection in a pre-filled syringe). The study focuses on how you respond to treatment over a period, specifically at 12 weeks (T12) and 24 weeks (T24).

During your participation, you would have regular visits with the study team. These visits will involve assessments to check how your psoriatic arthritis symptoms are improving. This will include physical examinations, possibly questions about your pain and daily activities, and assessments like ultrasound scans of your joints. Researchers will collect samples, likely blood or joint fluid, to look for those special markers (biomarkers) that might predict your response to Taltz. The total duration of your participation will include these follow-up periods.

Potenzielle Risiken und Vorteile

Taking part in this study might offer a potential benefit if Taltz helps improve your psoriatic arthritis symptoms, especially if other treatments haven't worked well for you. You would also be contributing valuable information that could help others with psoriatic arthritis in the future. As with any medication, there can be potential risks, including side effects from Taltz, which the study team will discuss thoroughly with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

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Häufige Fragen

Was ist Psoriasis-Arthritis?

It's a type of arthritis that affects some people with psoriasis, causing swollen, painful, and stiff joints.

What is Taltz?

Taltz is a medicine, often given as an injection, used to treat conditions like psoriatic arthritis.

What does 'biomarkers' mean?

Biomarkers are specific signals in your body that doctors can measure to understand how a disease is progressing or how you might respond to a treatment.

Warum ist diese Studie wichtig?

It aims to help doctors better predict which patients with psoriatic arthritis will benefit most from Taltz, leading to more personalised and effective treatment.

Is Taltz a new medicine?

No, Taltz is already approved for use. This study is about learning more about how it works and who benefits most in real-life situations.

Wie Sie mehr erfahren können

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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