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Aktiv, aber nicht rekrutierendPHASE3INTERVENTIONELL

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

This research study is looking into a new medicine, ixekizumab, for children and young people aged 2 to 17. It's for those with two specific types of juvenile arthritis: enthesitis-related arthritis (which includes a type of arthritis that can affect the spine called juvenile onset ankylosing spondylitis) and juvenile psoriatic arthritis. The main goal is to find out if ixekizumab is safe for these children and if it works well to help manage their arthritis symptoms. To understand its effects, we will be comparing it to another medicine, adalimumab, which is often used for these conditions. This is a Phase 3 study, meaning it's one of the final steps before a medicine might become more widely available.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE3
Sponsor
Eli Lilly und Unternehmen
Einschreibeziel
101
Starten
13 Apr 2021
Geschätzte Fertigstellung
01 Jan 2029
Juvenile Psoriasis-ArthritisEnthesitis Related Arthritis

Ergebnisse

Ergebnisse dieser Studie

Veröffentlicht June 2025

Die Ergebnisse dieser Studie wurden veröffentlicht.

Hauptausgang
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Vollständige Ergebnisse im Register

Worum geht es in dieser Studie?

Imagine you have persistent joint pain, swelling, or stiffness, especially in places where tendons or ligaments attach to bones, or along with skin problems. This is a reality for children and young people with certain types of juvenile arthritis. This study focuses on two specific kinds: enthesitis-related arthritis and juvenile psoriatic arthritis. These conditions can be very challenging, affecting daily life, school, and play, and they can sometimes lead to long-term problems if not managed well. Current treatments help manage the symptoms, but researchers are always looking for even better options that are safe and effective for children.

That's where this study comes in. We want to explore a new medicine called ixekizumab. This medicine works by targeting specific parts of the immune system that cause inflammation in these arthritis conditions. By doing so, it aims to reduce pain, swelling, and other symptoms, helping children feel better and improve their overall health and well-being.

We will be comparing ixekizumab with another medicine called adalimumab, which is already used for these conditions. This comparison helps doctors understand if ixekizumab is as good as, or perhaps even better than, existing treatments. The information gathered from studies like this is crucial for doctors to make informed decisions about the best ways to treat children with these challenging forms of arthritis in the future.

Wichtige Erkenntnisse

  • Study for children aged 2-17 with specific types of juvenile arthritis.
  • Testing a new medicine, ixekizumab, against an existing one, adalimumab.
  • Aims to check if ixekizumab is safe and effective in reducing arthritis symptoms.
  • Involves regular clinic visits and close health monitoring.
  • Die Teilnahme ist freiwillig, und Sie können jederzeit zurücktreten.

Wer könnte berechtigt sein?

This study is looking for children and young people between the ages of 2 and 17 years old. To join, they must have either active enthesitis-related arthritis (which sometimes includes juvenile onset ankylosing spondylitis) or active juvenile psoriatic arthritis. They also need to weigh at least 10 kilograms. If they have juvenile psoriatic arthritis, they must be at least 2 years old, and if they have enthesitis-related arthritis, they must be at least 6 years old. It's also important that all their routine childhood vaccinations are up-to-date, as advised by your doctor.

There are also some reasons why someone might not be able to join the study. For example, if they have certain other health problems like inflammatory bowel disease, an active eye condition called uveitis, or an active infection. They also cannot have ever had or currently have tuberculosis. If your child is already taking certain types of biological medicines for their arthritis, they wouldn't be able to join this study either.

The research team will carefully check all these requirements to make sure the study is a good fit for your child and that it would be safe for them to take part.

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. Is your child aged between 2 and 17 years old?
  2. Does your child have active enthesitis-related arthritis or juvenile psoriatic arthritis?
  3. Does your child weigh at least 10 kilograms?
  4. Are your child's routine vaccinations up-to-date?
  5. Does your child currently NOT have any active infections or other specific serious health conditions mentioned by the study team?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, the study team would perform various assessments to check your child's health and how their arthritis is responding to the treatment. This might include physical examinations, blood tests, and potentially other tests related to their arthritis. Your child would receive either the new study medicine, ixekizumab, or the comparison medicine, adalimumab. The treatments are usually given as an injection. The study team would explain exactly how and when to give the medicine. Throughout the study, the team would closely monitor your child for any side effects and to see how their arthritis symptoms are changing. After the main treatment period, there will be follow-up visits to continue to monitor their health. The total time your child would be involved in the study would depend on the specific study plan, which the research team would discuss with you in detail.

Potenzielle Risiken und Vorteile

Participating in this study might offer potential benefits, such as access to a new medicine that could improve your child's arthritis symptoms, and close medical monitoring by experts. However, like all medicines, ixekizumab and adalimumab can have side effects, and there's no guarantee that the treatment will help everyone. The research team will explain all the known and potential risks in detail. It's important to remember that your child's participation is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Standorte (43)

  • Instituto CAICI SRL Loc. 15
    Verifizierte Postleitzahl
    Rosario, Argentinien
  • Centro Medico Privado de Reumatologia Loc. 20
    Verifizierte Postleitzahl
    San Miguel de Tucumán, Argentina
  • Cliniques universitaires Saint-Luc
    Verifizierte Postleitzahl
    Brüssel, Belgien
  • UZ Gent
    Verifizierte Postleitzahl
    Gent, Belgien
  • UZ Leuven
    Verifizierte Postleitzahl
    Leuven, Belgien
  • Oddeleni revmatologie deti a dospelych Loc. 1
    Verifizierte Postleitzahl
    Prag, Tschechien
  • Dětská klinika Loc. 11
    Verifizierte Postleitzahl
    Olomouc, Czechia
  • Klinika detskeho a dorostoveho lekarstvi Loc. 1
    Verifizierte Postleitzahl
    Prag, Tschechien
  • Aarhus Universitetshospital, Skejby
    Verifizierte Postleitzahl
    Aarhus, Denmark
  • Service rhumatologie Loc.
    Verifizierte Postleitzahl
    Bron, France
  • Service de consultation pédiatrique Loc. 1
    Verifizierte Postleitzahl
    Montpellier, Frankreich
  • Rhumatologie pediatrique et CEREMAIA Loc. 1
    Verifizierte Postleitzahl
    Le Kremlin-Bicêtre, France

Häufige Fragen

Was ist juvenile idiopathische Arthritis?

Juvenile idiopathic arthritis (JIA) is a type of long-term arthritis that affects children and young people under the age of 16. It causes joint pain, swelling, and stiffness.

What are enthesitis-related arthritis and juvenile psoriatic arthritis?

These are two specific types of juvenile idiopathic arthritis. Enthesitis-related arthritis mainly affects places where tendons and ligaments attach to bones, while juvenile psoriatic arthritis occurs in children who also have a skin condition called psoriasis.

What is ixekizumab?

Ixekizumab is a new medicine being tested. It works by calming down parts of the immune system that cause inflammation in arthritis, aiming to reduce pain and swelling.

What is adalimumab?

Adalimumab is an existing medicine commonly used to treat certain types of arthritis, including some forms of juvenile idiopathic arthritis. It also works by affecting the immune system.

Will my child definitely get the new medicine?

This is a comparison study, so your child might receive either ixekizumab (the new medicine) or adalimumab (an existing medicine). The study team will explain how this is decided.

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