Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
This important study, called SMART-JIA, is for children aged 2 to 17 who have a type of arthritis called polyarticular juvenile idiopathic arthritis (JIA). These children have already tried an anti-TNF medicine (TNFi) but it hasn't fully controlled their symptoms. The study aims to find the best next medicine to try. Researchers will compare a second anti-TNF medicine against three other well-known arthritis medicines (Abatacept, Tocilizumab, and Tofacitinib). The goal is to discover the best way to choose medicines in a sequence, rather than through trial and error, to help children with JIA feel better sooner and improve their long-term health.
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¿De qué trata este estudio?
This study, called SMART-JIA, is designed to help children and young people aged 2 to 17 who have a type of arthritis called polyarticular juvenile idiopathic arthritis (JIA). This is a condition where a child's joints become inflamed, causing pain, swelling, and stiffness. Many children with JIA start treatment with a medicine called a TNF inhibitor (TNFi). However, for some, this first medicine doesn't work as well as hoped.
The main idea behind this study is to find the best 'second step' medicine for these children. Instead of guessing which medicine might work next, the researchers want to compare several established treatments directly. They will be looking at a second TNFi medicine and three other different types of medicines (Abatacept, Tocilizumab, and Tofacitinib), all of which are already approved and used for JIA. The study is set up to see which of these options works best when a child needs to switch their treatment.
What makes this study special is its 'smart' design. This means if a child doesn't respond well to the first study medicine they are given, they might have the chance to try a different medicine within the study. This approach helps researchers understand not just which single medicine is best, but also the best order or 'sequence' of medicines to try. The aim is to move away from a 'trial and error' approach and instead give doctors clear information to choose the most effective treatment for each child, helping them manage their arthritis better and faster.
Puntos clave
- A study for children aged 2-17 with JIA that hasn't fully responded to their first medicine.
- Compares different existing JIA treatments to find the best next steps.
- Aims to improve how doctors choose medicines for children with JIA.
- All medicines in the study are currently approved and used for JIA.
- Involves regular clinic visits, check-ups, and blood tests.
¿Quién puede ser elegible?
To be considered for this study, children must be between 2 and 17 years old and weigh at least 10kg. They need to have polyarticular JIA, a specific type of childhood arthritis, and their arthritis must still be quite active despite having taken their first TNF inhibitor medicine for at least three months. If they are taking steroids, the dose needs to be stable and not too high.
There are also some reasons why a child might not be able to join. For example, if they have other specific types of JIA (like systemic JIA), or if they have certain other health conditions like active inflammatory bowel disease, active psoriasis, active eye inflammation (uveitis), or have had certain cancers. Children who have already tried more than one TNF inhibitor, or other types of advanced arthritis medicines, also wouldn't be able to participate.
Finally, children will need to have certain blood test results within a healthy range and must not have active infections, especially tuberculosis. Parents or guardians will need to give their full permission for their child to take part.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Is your child aged between 2 and 17 years old?
- Does your child have polyarticular JIA?
- Has your child tried a first TNF inhibitor medicine for at least 3 months, but their JIA is still active?
- Does your child have generally good overall health, without certain serious infections or other specific health conditions?
- Are you able to provide informed consent for your child to participate?
¿En qué consiste la participación?
If your child takes part in this study, the doctors and nurses will explain everything in detail. Your child will be given one of the study medicines, which are all existing treatments for JIA. Some medicines are given as an injection under the skin (weekly, every other week, or every three weeks), and one is a tablet taken twice a day.
Your child will have regular visits to the clinic for assessments. These will include check-ups, physical examinations, and blood tests to monitor their arthritis and overall health. If your child doesn't respond well to the first study medicine they receive, the study design allows for a possible change to a different study medicine later on. The total length of time your child will be involved in the study will be discussed with you.
Riesgos y beneficios potenciales
Ubicaciones (6)
- University of California San Francisco Pediatric RheumatologyCódigo postal verificadoSan Francisco, Estados Unidos· Reclutamiento
- Universidad de FloridaCódigo postal verificadoGainesville, Estados Unidos· Reclutamiento
- Hackensack Meridian Health - Joseph M. Sanzari Children's HospitalCódigo postal verificadoHackensack, Estados Unidos· Reclutamiento
- Hospital Infantil NationwideCódigo postal verificadoColumbus, Estados Unidos· Reclutamiento
- Asklepios Children's HospitalCódigo postal verificadoSankt Augustin, Alemania· Reclutamiento
- IRCCS Giannina Gaslini InstituteCódigo postal verificadoGenoa, Italy· Reclutamiento
Preguntas comunes
What is polyarticular Juvenile Idiopathic Arthritis (JIA)?
It's a type of childhood arthritis where several joints are affected, causing pain, swelling, and stiffness.
What is a TNF inhibitor (TNFi)?
It's a type of medicine often used for JIA that helps reduce inflammation in the body.
Are the medicines used in this study new or experimental?
No, all the medicines being compared in this study are already approved and regularly used to treat JIA.
Will my child automatically get the best medicine?
Participants are randomly assigned to one of the study medicines. The goal is to discover which medicine or sequence of medicines works best overall.
How long will my child need to be in the study?
The study team will explain the expected duration of participation during your initial discussions.
Cómo obtener más información
Laura E Schanberg (Contact PI)
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.