RecruitingPhase IIIInterventional

A clinical trial of Baricitinib in Juvenile Dermatomyositis (BAR-JDM): comparing baricitinib and steroids to methotrexate and steroids over 52 weeks

Juvenile dermatomyositis (JDM) is a rare condition that affects children's muscles, skin, and blood vessels. Current treatments don't work for everyone and can have side effects. This study is testing a new medicine called baricitinib, which is already used for other conditions in adults and children. It works differently from current treatments by more directly targeting what causes inflammation. Researchers want to see if baricitinib, used alongside steroids, is better and safer than the usual treatment of methotrexate and steroids for children aged 2 to 17 who are newly diagnosed with JDM. Participants will be randomly placed into one of two groups and will be closely monitored for 52 weeks to understand the effects of the treatments. The aim is to find better ways to help children with JDM.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University College London

Enrolment target

Start

01 Jul 2025

Estimated completion

31 Mar 2028

Juvenile dermatomyositis (JDM)

What is this study about?

Juvenile dermatomyositis, or JDM, is a rare condition in children where their immune system mistakenly attacks their own body, causing problems with muscles, skin, and blood vessels. While there are treatments available, such as high-dose steroids and other medicines that calm the immune system (like methotrexate), they don't always work perfectly for every child and can have their own side effects. This means doctors are always looking for new and better ways to help children with JDM.

This study, called BAR-JDM, is exploring a new medicine called baricitinib. This medicine is already used for other types of arthritis in adults and children. It works in a more focused way to reduce the inflammation that causes JDM. The main goal of this study is to find out if baricitinib, when given with steroids, is a better and safer option than the standard treatment of methotrexate and steroids for children who have just been diagnosed with JDM.

Around 30 children from across the UK, aged between 2 and under 17 years old, will take part in this research. By comparing these two treatment approaches carefully over 52 weeks, the researchers hope to gather important information that could improve how JDM is treated in the future, offering more effective and potentially safer choices for children.

Key takeaways

A study comparing a new drug (baricitinib) with standard treatment for JDM.
For children aged 2-17 years with newly diagnosed JDM.
Treatment and monitoring will last for 52 weeks.
Participation involves regular hospital visits for checks and tests.
The goal is to find better and safer treatments for JDM.

Who may be eligible?

This study is specifically for children aged 2 years up to their 17th birthday who have recently been diagnosed with juvenile dermatomyositis (JDM) and haven't started any treatment for it yet. Their JDM needs to be causing active problems, like muscle weakness or other signs of inflammation.

There are also some reasons why a child might not be able to join the study. For example, if they have other types of muscle inflammation conditions, or if they've had a bad reaction to any of the study medicines before. Children who are pregnant or breastfeeding, or who could become pregnant, will not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 2 and 17 years old?
Has my child been newly diagnosed with juvenile dermatomyositis (JDM)?
Has my child not started any JDM treatment yet?
Does my child have active JDM symptoms like muscle weakness?
Is my child not pregnant or breastfeeding, if applicable?

Answer every question to see your result.

What does participation involve?

If your child joins the study, they will be randomly put into one of two groups, like flipping a coin – you won't be able to choose which group they are in. One group will take baricitinib tablets, and the other will have methotrexate injections, both for 52 weeks. Children in the baricitinib group might have their dose adjusted during the study. All children in both groups will also take steroids, with the dose slowly reduced over time.

There will be twice as many children receiving baricitinib than methotrexate. Before starting treatment, your child will have a 'Screening' visit to check if they can join, followed by a 'Baseline and Randomisation' visit. Then, they will have regular check-ups at their local research hospital at specific times: after 12, 24, 39, and 52 weeks. These visits will involve questionnaires, physical checks, and blood and urine tests to see how they are doing. At the very end of the study, there will be a final check-up, which might be a phone call or a clinic visit. Throughout the study, if your child needs extra treatment for their JDM, they will receive it as normal.

Potential risks and benefits

There is no guarantee of direct benefit for your child from taking part, but the information gained could help others with JDM in the future. The researchers believe the potential benefits of finding a more effective treatment outweigh the potential risks. Like all medicines, those in this study can have side effects. Common ones include infections, which are usually mild and manageable, like common colds, or cold sores. There's also a small chance of issues with the liver or blood clots, and strict monitoring will be in place to detect these early. You can withdraw your child from the study at any time without affecting their usual medical care.

Locations (12)

Great Ormond Street Hospital
Approximate
London, United Kingdom
Royal Hospital for Sick Children (Glasgow)
Approximate
Glasgow, United Kingdom
Alder Hey Children's Hospital
Approximate
Liverpool, United Kingdom
Evelina London Children's Hospital
Approximate
London, United Kingdom
Manchester Royal Infirmary
Approximate
Manchester, United Kingdom
Southampton Children's Hospital
City only
Southampton, United Kingdom
Cambridge University Hospital
Approximate
Cambridge, United Kingdom
Leeds Children's Hospital
Approximate
Leeds, United Kingdom
Great North Children's Hospital Newcastle
City only
Newcastle upon Tyne, United Kingdom
Nottingham Children's Hospital
City only
Nottingham, United Kingdom
Birmingham Children's Hospital
Unverified
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Unverified
Bristol, United Kingdom

Common questions

What is Juvenile Dermatomyositis (JDM)?

JDM is a rare condition where a child's immune system mistakenly attacks their muscles, skin, and blood vessels, causing inflammation.

What medicines are being studied?

The study compares baricitinib (a newer drug) with methotrexate (a standard drug), both given alongside steroids.

How long will the study last for my child?

Your child will receive treatment for 52 weeks, with follow-up visits throughout this period.

Will my child definitely get the new medicine?

No, children are randomly assigned to one of two groups – one gets baricitinib and the other gets methotrexate. You cannot choose the group.

Where is the study being run from?

The study is managed by University College London and involves NHS hospitals across the UK.

How to find out more

Rachel McComish

cctu.bar-jdm@ucl.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.