Ongoing Clinical Trials for Juvenile Idiopathic Arthritis
There are currently 15 clinical trials underway across Europe studying new treatments and strategies for managing juvenile idiopathic arthritis in children and adolescents. These trials are investigating medications including JAK inhibitors, TNF inhibitors, interleukin blockers, and other biologic therapies, as well as exploring treatment withdrawal strategies for patients in remission.
Clinical trial locations
- Austria
- Belgium
- Long-Term Study of Tofacitinib for Children and Teens with Juvenile Idiopathic Arthritis
- Study on Early Drug Withdrawal in Children with Juvenile Idiopathic Arthritis Using Secukinumab and Drug Combination for Those in Clinical Remission
- Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis
- Study on Upadacitinib and Tocilizumab for Children and Teens with Active Systemic Juvenile Idiopathic Arthritis
- Bulgaria
- Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
- Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis
- Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis
- Czechia
- Study on Early Drug Withdrawal in Children with Juvenile Idiopathic Arthritis Using Secukinumab and Drug Combination for Those in Clinical Remission
- Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis
- Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis
- Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis
- Denmark
- Finland
- France
- Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
- Study on Filgotinib for Children and Teens with Juvenile Idiopathic Arthritis
- Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis
- Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis
- Germany
- Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
- Study on Filgotinib for Children and Teens with Juvenile Idiopathic Arthritis
- Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis
- Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis
- Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis
- Study on Upadacitinib and Tocilizumab for Children and Teens with Active Systemic Juvenile Idiopathic Arthritis
- Study on the Effects and Safety of Upadacitinib for Children with Polyarticular Juvenile Idiopathic Arthritis
- Hungary
- Ireland
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Study of Sarilumab for Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)
This trial is investigating sarilumab for children and adolescents aged 1 to 17 years with systemic juvenile idiopathic arthritis. The medication is given as an injection under the skin and works by blocking the interleukin-6 receptor, which plays a role in inflammation.
Main inclusion criteria: Children must have at least 5 active joints with arthritis at screening, or if they have fewer than 5 active joints, they must have a fever higher than 37.5°C. Participants must not be responding well to current treatment and should be suitable for a biologic disease-modifying anti-rheumatic drug. The age requirement varies by country, with participants needing to be between 1 and 17 years old, or 12 and 17 years old in Russia.
Main exclusion criteria: Children with serious health conditions that could interfere with the study, those taking medications that might affect study results, those with recent infections or allergic reactions to similar medications, and those who are pregnant or breastfeeding cannot participate.
Trial focus: The study aims to determine the right dose and schedule of sarilumab for treating this condition. It includes an initial treatment phase where the medication is administered repeatedly and monitored closely, followed by a core treatment phase lasting up to 12 weeks where effectiveness and safety are assessed. An extension phase continues monitoring up to week 156 to evaluate long-term benefits and risks.
Investigational drug: Sarilumab is administered through subcutaneous injection and is being studied in clinical trials for treating systemic juvenile idiopathic arthritis.
Study on Early Drug Withdrawal in Children with Juvenile Idiopathic Arthritis Using Secukinumab and Drug Combination for Those in Clinical Remission
This trial explores whether stopping medication early in children who have been in clinical remission for at least six months is safe and effective. The medications being studied include secukinumab, baricitinib, methotrexate, etanercept, tocilizumab, tofacitinib, golimumab, and abatacept.
Main inclusion criteria: Children diagnosed with specific types of juvenile idiopathic arthritis who have had inactive disease for at least 6 continuous months while on medication. They must be taking specific antirheumatic drugs according to recommended guidelines and be able to provide written informed consent along with their parents.
Main exclusion criteria: Patients who have not achieved 6 months of clinical inactive disease with medication or who have subclinical inflammation that can be detected through medical tests cannot participate.
Trial focus: The study compares maintaining medication against two different withdrawal strategies to see which approach better prevents disease flare-ups. Participants are randomly assigned to different groups and monitored over time to assess outcomes.
Investigational drugs: Various antirheumatic agents are being studied to determine if they can be safely stopped early based on certain health markers.
Study on Filgotinib for Children and Teens with Juvenile Idiopathic Arthritis
This trial is studying filgotinib, available as 100 mg and 200 mg film-coated tablets, for children and teenagers aged 8 to less than 18 years with juvenile idiopathic arthritis. The medication works by inhibiting Janus kinases, enzymes involved in the inflammation process.
Main inclusion criteria: Children must have a body mass index within the 5th to 95th percentiles for their age and gender and weigh at least 15 kg. They must have one of several types of juvenile idiopathic arthritis with moderately to severely active disease not well controlled by current treatment. Participants must have had an intolerance or inadequate response to at least one medication used for the condition for at least 12 weeks.
Main exclusion criteria: Patients with serious health conditions, those taking medications that might affect study results, those with recent infections or allergic reactions to similar medications, and those who are pregnant or breastfeeding cannot participate.
Trial focus: The study aims to understand how the body processes filgotinib in young patients and to assess its safety and tolerability. Multiple doses will be administered and monitored over time.
Investigational drug: Filgotinib is administered orally in tablet form and is being studied for its effectiveness in treating juvenile idiopathic arthritis.
Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis
This trial evaluates the long-term safety of secukinumab for various inflammatory conditions, including juvenile idiopathic arthritis. The medication is administered as a subcutaneous injection.
Main inclusion criteria: Participants must have completed a previous study involving secukinumab and be benefiting from the treatment. They must provide signed informed consent, and minors require written informed assent and parental permission. Participants must not have access to the marketed form of secukinumab through local prescription.
Main exclusion criteria: Patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis cannot participate.
Trial focus: The study monitors long-term safety over up to 104 weeks, observing for any adverse events or reactions at the injection site.
Investigational drug: Secukinumab is a biologic drug that targets interleukin-17A to reduce inflammation in various inflammatory conditions.
Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis
This trial tests deucravacitinib, taken as a film-coated tablet, for children and teenagers aged 5 to 18 with juvenile psoriatic arthritis. The medication is a selective tyrosine kinase 2 inhibitor that reduces inflammation.
Main inclusion criteria: Participants must be diagnosed with juvenile psoriatic arthritis, which causes both joint inflammation and skin symptoms similar to psoriasis.
Main exclusion criteria: Details not fully specified in the source data.
Trial focus: The study compares deucravacitinib to a placebo to determine effectiveness in managing symptoms. It monitors how long it takes for disease flare-ups to occur and assesses improvement in symptoms, tolerability, and side effects over time.
Investigational drug: Deucravacitinib is being studied in a Phase 3 clinical trial to assess its effectiveness and safety in treating juvenile psoriatic arthritis.
Study on the Safety and Body Processing of Bimekizumab in Children with Juvenile Idiopathic Arthritis
This trial studies bimekizumab for children aged 2 to less than 18 years with enthesitis-related arthritis or juvenile psoriatic arthritis. The medication is given as a subcutaneous injection.
Main inclusion criteria: Participants must have a confirmed diagnosis of enthesitis-related arthritis or juvenile psoriatic arthritis for at least 6 months. They must have active disease with at least 3 active joints and have had an inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug. Participants must weigh at least 10 kg.
Main exclusion criteria: Patients with other active autoimmune diseases, serious infections in the past 3 months, recent live vaccines, history of cancer, pregnancy or breastfeeding, and those with known allergies to the study medication cannot participate.
Trial focus: The study aims to learn if bimekizumab is safe and how it moves throughout the body. It monitors growth, vital signs, and any adverse events, while also assessing treatment response using specific criteria.
Investigational drug: Bimekizumab is a monoclonal antibody that blocks proteins involved in inflammation.
Study on the Safety and Effectiveness of Adalimumab and Etanercept in Children with Active Juvenile Idiopathic Arthritis
This trial compares the original versions of adalimumab and etanercept with their biosimilar versions in children with juvenile idiopathic arthritis who are in clinical remission. Both medications are TNF inhibitors that reduce inflammation.
Main inclusion criteria: Children aged 2 to less than 18 years diagnosed with juvenile idiopathic arthritis who are candidates for anti-TNF treatment. They must have moderate to high disease activity despite methotrexate treatment for at least 3 months and meet specific weight requirements for certain medications.
Main exclusion criteria: Patients not in clinical remission, not currently on anti-TNF medication, or not previously treated with adalimumab or etanercept cannot participate.
Trial focus: The study evaluates whether switching between original and biosimilar medications is safe and effective, monitoring for disease flare-ups over 18 months.
Investigational drugs: Adalimumab and etanercept are TNF inhibitors administered via injection to manage symptoms.
Study on the Safety and Effectiveness of Baricitinib for Children Aged 1 to 17 with Juvenile Idiopathic Arthritis
This trial examines the long-term safety and effectiveness of baricitinib for children aged 1 to less than 18 years with juvenile idiopathic arthritis. The medication is taken orally as a tablet or suspension.
Main inclusion criteria: Participants must have completed a previous baricitinib study for juvenile idiopathic arthritis and must not have developed an allergy to the medication.
Main exclusion criteria: Details not fully specified in the source data.
Trial focus: The study monitors participants to observe any side effects and to see how well the medication works over an extended period, gathering information on long-term use.
Investigational drug: Baricitinib is a JAK inhibitor that helps reduce inflammation by blocking specific enzymes involved in the inflammatory process.
Study on Treatment Strategies for Children and Adolescents with Juvenile Idiopathic Arthritis Using Methotrexate and Drug Combination
This trial compares continuing stable treatment with methotrexate and TNF inhibitors against two different withdrawal strategies for children and adolescents with juvenile idiopathic arthritis in sustained remission.
Main inclusion criteria: Children aged 2 to 18 years with non-systemic juvenile idiopathic arthritis in sustained clinical remission for at least 12 months. They must have had at least two visits confirming inactive disease and be on stable treatment with a TNF inhibitor and methotrexate for at least 3 months.
Main exclusion criteria: Patients without sustained inactive disease for at least 12 months or not meeting the other specified criteria cannot participate.
Trial focus: The study assesses the risk of disease flares when gradually withdrawing medication compared to continuing treatment, monitoring patients over 12 months.
Investigational drugs: Methotrexate and TNF inhibitors are used to manage symptoms and control disease progression.
Study on Upadacitinib and Tocilizumab for Children and Teens with Active Systemic Juvenile Idiopathic Arthritis
This trial studies upadacitinib, taken orally, and tocilizumab, administered by injection or infusion, for children and adolescents with active systemic juvenile idiopathic arthritis.
Main inclusion criteria: Children must be between 1 and less than 18 years old and weigh at least 10 kg. They must have specific blood test results within normal limits, including liver enzymes, kidney function, and blood cell counts.
Main exclusion criteria: Patients with serious health conditions, those taking interfering medications, those with recent infections or allergies to study medications, and those who are pregnant or breastfeeding cannot participate.
Trial focus: The study evaluates how these treatments affect disease activity, observes side effects, and understands how the drugs are processed in the body over up to 52 weeks.
Investigational drugs: Upadacitinib is a JAK inhibitor, while tocilizumab is a monoclonal antibody that blocks the interleukin-6 receptor to reduce inflammation.
Summary
The 15 ongoing clinical trials for juvenile idiopathic arthritis represent a diverse research effort across multiple European countries. Italy leads with 7 trials, followed by Spain with 6, and Germany with 6 trials. Several countries including France, Poland, Belgium, and Czechia are also actively participating in multiple studies.
The trials focus primarily on biologic therapies and JAK inhibitors, with particular attention to medications such as upadacitinib, baricitinib, adalimumab, etanercept, secukinumab, and tocilizumab. A notable trend is the investigation of treatment withdrawal strategies for patients who have achieved remission, which could potentially reduce treatment burden while maintaining disease control.
Most trials include children and adolescents ranging from 1 to 18 years of age, though specific age requirements vary by study and medication. The studies address various subtypes of juvenile idiopathic arthritis, including systemic forms, polyarticular disease, enthesitis-related arthritis, and juvenile psoriatic arthritis. Several trials are examining long-term safety and effectiveness, with some extending monitoring periods up to several years.
The research emphasizes personalized treatment approaches, including the use of biomarkers to guide therapy decisions and comparative studies between original medications and biosimilar versions. These trials aim to improve understanding of optimal treatment strategies, reduce unnecessary medication exposure, and enhance quality of life for children living with juvenile idiopathic arthritis.
