Clinical trials on Juvenile idiopathic arthritis

Juvenile Idiopathic Arthritis (JIA) is a chronic inflammatory disease that affects children under the age of 16. It causes persistent joint inflammation, resulting in pain, swelling, and stiffness. The inflammation can limit movement and cause joint damage if left untreated. JIA can also be associated with other symptoms such as fever and rash.

Complications

  • Joint Damage: Untreated JIA can lead to permanent joint damage and deformities.
  • Growth Problems: The disease or its treatment can affect bone growth, leading to shorter stature.
  • Eye Inflammation: Uveitis, or inflammation inside the eye, can occur, potentially leading to vision loss if untreated.
  • Systemic Issues: Severe cases can affect internal organs, causing symptoms like fever, rash, and anemia.
  • Reduced Mobility: Chronic pain and stiffness can limit physical activities, affecting the child’s quality of life.

Treatment Methods

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Used to reduce pain and inflammation.
  • Disease-Modifying Antirheumatic Drugs (DMARDs): Medications like methotrexate help slow disease progression.
  • Biologic Agents: Target specific parts of the immune system, examples include etanercept, adalimumab, and tocilizumab.
  • Corticosteroids: Used to control severe inflammation, typically in short-term treatments.
  • Physical Therapy: Helps maintain joint function and range of motion.

Prognosis

  • With Treatment: Many children experience significant improvement, and some may achieve remission. Early and effective treatment can prevent joint damage and preserve function.
  • Without Treatment: The disease can lead to severe joint damage, disability, and complications affecting other organs. Regular monitoring and a comprehensive treatment plan are crucial for managing symptoms and improving long-term outcomes.
  • CT-EU-00118080

    Evaluating upadacitinib and tocilizumab in pediatric and adolescent patients with active systemic juvenile idiopathic arthritis

    This clinical trial is designed for pediatric and adolescent participants aged 1 to less than 18 years with systemic Juvenile Idiopathic Arthritis (sJIA). The study aims to evaluate the safety and effectiveness of upadacitinib, an oral medication, and includes a reference arm for tocilizumab, which can be administered subcutaneously or intravenously.

    Participants will be assigned to one of two cohorts. Cohort 1 (group) will receive either upadacitinib or tocilizumab, while Cohort 2 will receive upadacitinib only. The treatment period will last 52 weeks, followed by a 30-day follow-up. The study will monitor changes in disease activity and adverse events through regular visits and assessments.

    • Tocilizumab
    • Upadacitinib
  • Evaluating the pharmacokinetics, safety, and tolerability of Filgotinib in children and teenagers with juvenile idiopathic arthritis

    This clinical trial focuses on children and teenagers aged 8 to less than 18 years who have Juvenile Idiopathic Arthritis (JIA). The study aims to evaluate the pharmacokinetics, safety, and tolerability of filgotinib, an oral medication.

    Participants will be divided into three groups based on their body weight and will receive different doses of filgotinib in the form of film-coated tablets taken once daily. The trial will monitor the maximum concentration of the drug in the blood, the area under the concentration-time curve, and any adverse events over a period of up to 96 weeks.

    • Filgotinib
  • Baricitinib study in children with juvenile idiopathic arthritis

    This clinical trial is designed to test whether Baricitinib is safe and effective in the treatment of systemic juvenile idiopathic arthritis in children aged 1 to 18 years. Participants will be assigned to one of two groups. In the first group, some participants will receive Baricitinib and others Tocilizumab as the reference drug. In the second group, all participants will receive Baricitinib.

    The primary objective of the study is to evaluate the percentage of participants who experience at least a 30% improvement in disease symptoms after 12 weeks of treatment according to the modified American College of Rheumatology Pediatric Response Criteria (PediACR30). Baricitinib is administered orally and Tocilizumab is administered by subcutaneous injection.

    • Tocilizumab
    • baricitinib
  • Study of sarilumab in the treatment of juvenile idiopathic arthritis in children and adolescents

    This is a trial that aims to find the right dose of a drug called sarilumab for treating children and teenagers aged 1 to 17 years old with Systemic Juvenile Idiopathic Arthritis. Sarilumab is given as an injection under the skin. The main goal is to understand how the body processes this drug in young patients, so they can receive an adequate dose for treating their condition.

    The study will last for about 166 weeks, which is a little over 3 years. It starts with a 4-week screening period, followed by a 12-week treatment phase where the patients will receive repeated doses of sarilumab. After that, there is a 144-week extension phase where the patients can continue receiving the drug, and finally a 6-week follow-up period.

    During the first 12 weeks, the researchers will closely monitor the levels of sarilumab in the patients’ blood to understand how their bodies handle the drug. They will look at the maximum concentration reached, the total amount of drug exposure over time, and the levels just before each new dose. This information will help them determine the right dose and dosing schedule for children and adolescents with Systemic Juvenile Idiopathic Arthritis.

    In addition to studying the drug levels, the researchers will also evaluate the effectiveness of sarilumab in reducing the symptoms of this condition and monitor any potential side effects to ensure the drug is safe for long-term use in this age group.

    • Sarilumab
  • A clinical trial evaluating Baricitinib in young people with juvenile idiopathic arthritis

    This study focuses on systemic Juvenile Idiopathic Arthritis (sJIA) in children aged 1 to less than 18 years old. It aims to evaluate the long-term safety and efficacy of baricitinib, an oral medication. Participants will receive baricitinib daily and undergo regular assessments to monitor the drug’s effectiveness and any adverse effects. Key measures include the number of serious adverse events and the proportion of participants achieving minimal disease activity and remission. The study duration extends to at least 264 weeks, or approximately 5 years.

    • Baricitinib