Ongoing Clinical Trials for Still’s Disease
There are currently 3 ongoing clinical trials investigating treatments for Still’s disease, also known as Systemic Juvenile Idiopathic Arthritis. These studies are testing medications that aim to reduce inflammation and control symptoms in children and adolescents. The trials are being conducted across multiple European countries, including the Netherlands, Germany, Italy, Spain, and several others, offering opportunities for young patients to access new treatment approaches.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Italy
- Netherlands
- Poland
- Romania
- Spain
Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis
This trial is investigating deucravacitinib, a medication taken as a tablet, for treating Juvenile Psoriatic Arthritis in children and adolescents aged 5 to 18 years. Participants must have a confirmed diagnosis of this condition, which involves both joint inflammation and skin symptoms similar to psoriasis.
Inclusion criteria: Young patients must have been diagnosed with Juvenile Psoriatic Arthritis, meaning they experience both arthritis and skin problems like psoriasis.
Main focus: The study aims to determine whether deucravacitinib is more effective than a placebo in managing symptoms. Researchers will monitor how long it takes for disease flare-ups to occur, measure improvement in symptoms at weeks 16 and 42, and assess how well the medication is tolerated. The trial includes an initial treatment phase, followed by a randomized withdrawal phase where some participants may temporarily stop the medication to compare outcomes. Long-term evaluation will track the number of participants achieving low or no disease activity and measure improvements in skin symptoms.
Investigational drug: Deucravacitinib is a selective tyrosine kinase 2 inhibitor that works by reducing inflammation in the body. It is administered orally and is designed to help control joint pain, swelling, and skin symptoms associated with this type of arthritis.
Study on the Safety and Effectiveness of Baricitinib and Tocilizumab for Children with Systemic Juvenile Idiopathic Arthritis
This clinical trial is evaluating baricitinib, a medication available as tablets or oral suspension, compared with tocilizumab and placebo for treating Systemic Juvenile Idiopathic Arthritis in children aged 1 to less than 18 years.
Inclusion criteria: Participants must have a diagnosis of Systemic Juvenile Idiopathic Arthritis, with arthritis in at least one joint and a fever lasting at least 2 weeks with daily fever for at least 3 days. They must also have at least one additional symptom such as a temporary red rash, swollen lymph nodes, an enlarged liver or spleen, or inflammation around the heart or lungs. Additionally, participants must have at least 2 joints actively affected by arthritis and be at least 2 years old. Both boys and girls can participate.
Exclusion criteria: The trial excludes patients with other serious health conditions that could interfere with the study, those currently taking medications that might affect results, those with recent infections or illnesses, anyone with a history of allergic reactions to similar medications, and those unable to follow study procedures. Patients who have participated in another recent clinical trial, are pregnant or breastfeeding, have a history of substance abuse, have certain mental health conditions, or have received certain vaccines recently are also excluded.
Main focus: The primary goal is to measure the percentage of participants achieving the Adapted Pediatric American College of Rheumatology 30 response criteria at week 12, which indicates a significant improvement in symptoms. The study will monitor participants throughout the treatment phase with regular assessments including physical examinations and laboratory tests to evaluate both safety and effectiveness.
Investigational drugs: Baricitinib is a Janus kinase inhibitor that works by reducing inflammation in the body. It is administered orally and aims to control arthritis symptoms. Tocilizumab is used as a reference medication in this study and is given as a subcutaneous injection. It blocks a specific protein that causes inflammation.
Study on Anakinra for Children with Systemic Juvenile Idiopathic Arthritis
This trial is exploring a new treatment strategy using anakinra, an injectable medication, for children with Systemic Juvenile Idiopathic Arthritis. The study is investigating whether a specific blood marker called IL-18 can help guide treatment decisions and potentially reduce the number of injections needed.
Inclusion criteria: Participants must be children and adolescents aged 8 months to 16 years diagnosed with Systemic Juvenile Idiopathic Arthritis. Both male and female patients can participate. Parents or legal guardians must be willing to sign consent forms. For the treatment phase, patients must have been treated with anakinra as their first treatment and shown an initial positive response, meaning no fever by the seventh day of treatment. They must also achieve at least a 90% improvement in symptoms without fever around 90 days after starting treatment.
Exclusion criteria: The trial excludes patients with any other autoimmune disorders, which are conditions where the immune system attacks the body’s own tissues. It also excludes those with any other joint disorders or patients specifically diagnosed with Still’s disease or systemic Juvenile Idiopathic Arthritis as separate conditions.
Main focus: The study aims to determine the average number of injections required to maintain inactive disease within the first year of treatment. It will monitor initial responses to treatment, including the absence of fever by day 7 and significant symptom improvement around 90 days. The trial includes a tapering and stop phase where medication is gradually reduced and eventually stopped, guided by IL-18 biomarkers. Researchers will also track disease flares, the need for alternative treatments, and the number of participants achieving remission without medication after one and two years.
Investigational drug: Anakinra is an interleukin-1 receptor antagonist administered as a subcutaneous injection. It works by blocking the activity of interleukin-1, a protein that contributes to inflammation and joint damage. This helps reduce inflammation and control symptoms of the disease.
Summary
These three clinical trials offer different treatment approaches for children and adolescents with forms of juvenile arthritis related to Still’s disease. The trials are spread across multiple European countries, with the most comprehensive geographic coverage in the baricitinib and tocilizumab study, which spans seven countries. Two trials focus specifically on Systemic Juvenile Idiopathic Arthritis, testing baricitinib and anakinra, while one addresses Juvenile Psoriatic Arthritis with deucravacitinib.
A notable aspect of these studies is the variety of medication mechanisms being explored. Baricitinib and deucravacitinib both work by inhibiting specific enzymes involved in inflammation, though they target different pathways. Anakinra takes a different approach by blocking inflammatory proteins directly. The anakinra trial in the Netherlands is particularly innovative in its use of biomarkers to guide treatment decisions, potentially reducing the treatment burden for young patients.
All three trials emphasize careful monitoring of safety and effectiveness, with regular assessments throughout the treatment period. The studies aim not only to control symptoms but also to achieve disease remission and improve quality of life for children living with these chronic inflammatory conditions.
