Steroid Treatment Trial in JIA (STAR-JIA): A randomised trial to compare the effectiveness, safety and cost-effectiveness of intravenous versus oral corticosteroid induction regimens for children and young people with juvenile idiopathic arthritis

Alder Hey Children's NHS Foundation Trust0 个研究点目标入组 130 人开始时间: 2023年9月8日最近更新: 2024年1月15日

适应症

试验速览

暂无简介。

•1. Participants must be between 1-18 years of age inclusive
•2. New onset pcJIA diagnosed by a paediatric rheumatologist (to include polyarticular rheumatoid factor (RF+) positive, polyarticular RF negative, enthesitis-related arthritis, psoriatic arthritis and extended oligo-articular). This includes new diagnosis of JIA with at least 5 joints affected and patients previously categorised as oligoarticular JIA (with 4 joints or less) who have extended to at least 5 joints.
•3. Participants are expected to be able to commence allocated treatment within 1 week of randomisation
•4. Written, informed consent and where appropriate, assent obtained from participant or their legal representative
•5. Participants of child-bearing potential must be willing to abstain from sexual intercourse from consent to their final visit and/or use another acceptable contraception method as described in section 9.10.5 of this protocol

•1. Any contraindication to starting corticosteroids
•2. Any contraindication to starting methotrexate
•3. Pregnancy
•4. Treatment with systemic corticosteroids within 4 weeks preceding screening (includes IV, IA, IM and oral)
•5. Treatment with methotrexate within 12 weeks preceding screening
•6. Any co-morbidity which in view of the treating clinician makes participation inappropriate

发起方