Juvenile Idiopathic Arthritis (JIA) affects approximately 12,000 children and young people in the UK. It can cause significant pain and joint stiffness which can have a major impact on daily life and education. It is important to treat JIA quickly and effectively to ensure that children and young people can return to normal activity and to prevent long-term joint damage.

Corticosteroids are important for treating JIA in the short-term as they quickly reduce inflammation. Other medications such as Methotrexate may take up to 12 weeks before patients see a benefit.

The results from this study will be used to help us improve treatment for patients with JIA.

Participants will be assigned at random one of two types of steroid treatment:

1. Methylprednisolone given via a drip into a vein each day for 3 days on a Day Unit

2. Prednisolone tablet or solution taken by mouth over 6 weeks at home

Participation will involve attending study visits which will take place on the same day as standard JIA hospital appointments over a period of 52 weeks.

Corticosteroids and Methotrexate are commonly offered as first line treatment for JIA in the UK but there is limited evidence as to whether corticosteroids given intravenously work as well as corticosteroids taken by mouth.

STAR-JIA will investigate the efficacy, safety and cost-effectiveness of intravenous and oral corticosteroids in the treatment of JIA. We also want to find out which route is most acceptable to patients and their caregivers. Participants will receive corticosteroids as part of this study and, if appropriate, methotrexate as standard care. Participation is voluntary. The decision an individual makes on whether or not to take part (or for their child to take part) will not affect the standard or quality of care they receive now or in the future. The primary objective of the study to assess response to treatment with corticosteroids, after treatment has been completed, using the Juvenile Arthritis Disease Activity Score called the JADAS10 and recording changes in the JADAS10 score between first trial visit (Week 0 – Baseline) and the second trial visit 6 weeks later.

Patients diagnosed with a new onset polyarticular JIA.

If you think you may be eligible and would like to find out more about the study, you can enquire about the trial at your local hospital. If you want to find out more about the study but are not seeking to take part, contact star-jia@liverpool.ac.uk.

https://redcap02.lctc.org.uk/Star-jia/

Trial Newsletter (to be added)