STAR-JIA
Research type
Research Study
Full title
Steroid Treatment Trial in JIA (STAR-JIA): A randomised trial to compare effectiveness, safety and cost-effectiveness of intravenous versus oral corticosteroid induction regimens for children and young people with juvenile idiopathic arthritis.
IRAS ID
1007610
Contact name
Clare Pain
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Research summary
Aim: To compare two different steroid treatments in children and young people with new onset polyarticular juvenile idiopathic arthritis (JIA) to find out which is best.
Medications used in long¬term management of JIA take around 12 weeks to start working. Steroids act quickly, reducing inflammation whilst the other medications start to work but have many potential side-effects . There is a lack of evidence to suggest whether intravenous steroids or oral steroids are more effective, safe, tolerable for patients and which have a greater impact on quality of life.
Design: Patients age 1-18 years of age with at least 5 inflamed joints and newly diagnosed polyarticular JIA will be invited to take part. They will be randomised to either: 1) A 6-week course (reducing dose regimen) of prednisolone liquid or tablets, taken at home OR
2) A 3-day course of intravenous methylprednisolone on a hospital day-case unit. Participants will be assessed before starting treatment (baseline) and four follow-up visits at 6 weeks, 12 weeks, 24 weeks and 52 weeks, in line with standard care appointments. Study visits will include assessments in standard care however, additional study-specific assessments will include reporting of side-effects, steroid toxicity risk including extra blood tests, questionnaires relating to impact of JIA and treatment on quality of life and cost. The study offers an option for participants to donate blood samples for storage in a biobank for future research. Samples will not be analysed as part of the study but adopted by Liverpool University Biobank. There is a JIA patient and public involvement focus group that contribute to development of study information sheets and animation videos for participants and parents/guardians, protocol and dissemination of results. Results of this research study will be shared with healthcare professionals, participants/care-givers and the public including medical conferences and online journals.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0173
Date of REC Opinion
6 Sep 2023
REC opinion
Further Information Favourable Opinion