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Study on the Effectiveness of Triamcinolone Hexacetonide Injections for Juvenile Idiopathic Arthritis in Patients Starting TNF Inhibitor Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Juvenile Idiopathic Arthritis (JIA), a condition that causes joint inflammation in children. The trial is investigating the effectiveness of a treatment involving intra-articular glucocorticoid injections, which are injections directly into the joints, in combination with a medication called Tumour Necrosis Factor inhibitor (TNFi). The specific glucocorticoid used in this study is triamcinolone hexacetonide, marketed under the name Lederspan. The purpose of the study is to determine if these joint injections can help more children with JIA achieve a state where their disease is inactive, compared to those who do not receive the injections.

Participants in the study will be randomly assigned to one of two groups. One group will receive the joint injections along with their TNFi treatment, while the other group will receive only the TNFi treatment. The study will be conducted over a period of time, during which the health of the participants will be monitored to see if the joint injections help in maintaining inactive disease without the need for additional glucocorticoid use.

The trial aims to provide valuable information on whether adding joint injections to the standard TNFi treatment can improve outcomes for children with JIA. This could potentially lead to more personalized treatment strategies for managing this condition. The study is designed to ensure that all participants are carefully monitored and assessed by healthcare professionals throughout the trial period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age between 1-18 years, a diagnosis of juvenile idiopathic arthritis (JIA), and a clinical indication for starting treatment with a type of medication called a tumour necrosis factor inhibitor (TNFi).
Consent is required from participants aged 16 and above, or from guardians for those under 16. Both participants and guardians must consent if the participant is between 16-18 years old.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the disease activity using the Juvenile Disease Activity Score (JADAS). This score must be greater than 1, and at least one joint must show active arthritis where an injection is considered.
Step 3
Treatment phase
Participants are randomly assigned to receive either intra-articular glucocorticoid injections or no joint injections while starting TNFi treatment. The glucocorticoid used is triamcinolone hexacetonide, administered as a suspension for injection, known as Lederspan.
The objective is to determine if these injections help achieve a sustained inactive disease state compared to those who do not receive the injections.
Step 4
Monitoring and follow-up
Participants are monitored over a period to assess the effectiveness of the treatment. The primary goal is to achieve sustained inactive disease without the use of additional glucocorticoids from week 24 to 36.
Secondary assessments include a 30% improvement in the paediatric American College of Rheumatology criteria by week 24.
Step 5
Completion of the study
The study is expected to conclude by March 2025. Participants' progress and outcomes are evaluated to determine the effectiveness of the treatment strategies.

Who can join the trial?

6 criteria

Age between 1 and 18 years at the time of signing the informed consent.
Meet the criteria set by the International League of Associations for Rheumatology (ILAR) for non-systemic **Juvenile Idiopathic Arthritis (JIA)**, which is a type of arthritis that affects children.
Need to start **Tumour Necrosis Factor (TNF) inhibitor (TNFi)** treatment, as agreed upon by at least two doctors. TNFi is a type of medication used to reduce inflammation.
Have not used TNFi before or have used it only once, but stopped at least 3 months before joining the study, and did not have any treatment failure with TNFi.
Have a **Juvenile Disease Activity Score (JADAS)** greater than 1 at the start of the study and at least one joint with active arthritis where a joint injection is considered. JADAS is a way to measure how active the arthritis is.
Willing to provide written consent to participate in the study. If the participant is 16 or older, they can give consent themselves. If they are younger than 16, their guardians must give consent. If they are between 16 and 18, both the participant and their guardians must give consent.

Who cannot join the trial?

7 criteria

Patients who have a different condition than Juvenile Idiopathic Arthritis cannot participate. This condition is a type of arthritis that affects children.
Patients who are not within the age range specified for the study cannot participate. The study is for children aged 2 years and older.
Patients who are not starting treatment with a Tumour Necrosis Factor (TNF) inhibitor cannot participate. TNF inhibitors are medications used to reduce inflammation.
Patients who are unable to receive intra-articular glucocorticoid injections cannot participate. These are injections given directly into the joint to reduce inflammation.
Patients who are not able to follow the study procedures or attend study visits cannot participate.
Patients who have any other medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Verified
Helse Stavanger HF
Stavanger, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Glucocorticoid Injections
are used in this trial to treat joints with active arthritis in patients with Juvenile Idiopathic Arthritis (JIA). These injections are given directly into the affected joints to help reduce inflammation and pain. The goal is to see if these injections can help patients achieve a state where their disease is inactive for a longer period.
Tumour Necrosis Factor Inhibitors (TNFi)
are medications used to reduce inflammation by blocking a specific protein in the body that causes inflammation. In this trial, patients with JIA are starting treatment with these inhibitors to see if they can help control the disease and improve symptoms.

Triamcinolone Hexacetonide

What is already known about the treatment

Glucocorticoid Injections
These are administered directly into the joints through an injection. They are currently being studied in clinical trials for their effectiveness in treating Juvenile Idiopathic Arthritis (JIA). The main therapeutic indication is to reduce inflammation and pain in joints affected by arthritis. At the molecular level, glucocorticoids work by suppressing the immune system and decreasing the production of substances that trigger inflammation. They are classified as anti-inflammatory medications.
Tumor Necrosis Factor Inhibitors (TNFi)
These are typically administered via injection or infusion. They are well-established in medical literature for treating various inflammatory conditions, including Juvenile Idiopathic Arthritis. The primary therapeutic use is to reduce inflammation and halt disease progression. TNFi work by blocking the activity of tumor necrosis factor, a substance in the body that causes inflammation in the joints. They belong to the class of biologic medications.

Investigated diseases

Juvenile Idiopathic Arthritis – This is a type of arthritis that occurs in children under the age of 16. It is characterized by persistent joint inflammation, which can lead to pain, swelling, and stiffness. The disease can affect one or multiple joints and may also cause symptoms such as fever and rash. Over time, it can lead to joint damage and growth problems if not managed properly. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The progression of the disease can vary, with some children experiencing symptoms for only a few months, while others may have symptoms for many years.