None listed
Conditions
Brief summary
This prospective, open-label, multi-centre national randomised controlled trial (RCT) will assess strategies for methotrexate (MTX) dose reduction and discontinuation in children with nonsystemic juvenile idiopathic arthritis (nsJIA) in stable, minimally active disease, defined as clinically inactive disease (CID) or low disease activity (LDA). The primary outcome is disease flare; secondary outcomes include recapture rates, time to recapture, Wallace Criteria, JADAS71, ACR core variables, and patient-reported measures (JAMAR, CHAQ, PROMIS-25, EQ-5D-Y-5L). The trial also incorporates biospecimen collection and data linkages via the A3BC Registry & Biobank, qualitative research, health economic analysis, exploration of lived experiences, and predictive model development. Participation offers patients, families, and clinicians enhanced support and a structured environment to collaboratively assess flares. Findings will inform treatment decisions and improve care pathways for children with JIA.
Interventions
Participants in CHAMPION-MTX are cared for by their usual paediatric rheumatologist, who will act as Principal Investigators or Associate Investigators in this project, with the support of a Research Assistant.
A run-in period of 3 months will be undertaken by all eligible patients.
If still eligible at the end of this run-in period, participants will then be randomised at a baseline visit in a 1:1 ratio to either immediate cessation (Arm 1 “STOP”), or gradual dose-reduction (Arm 2 “TAPER”) of
Participants in CHAMPION-MTX are cared for by their usual paediatric rheumatologist, who will act as Principal Investigators or Associate Investigators in this project, with the support of a Research Assistant. A run-in period of 3 months will be undertaken by all eligible patients. If still eligible at the end of this run-in period, participants will then be randomised at a baseline visit in a 1:1 ratio to either immediate cessation (Arm 1 “STOP”), or gradual dose-reduction (Arm 2 “TAPER”) of methotrexate. Arm 1 participants are involved in CHAMPION-MTX for 12 months. The location of the intervention will be in the participant's home as per their usual treatment plans and according to their usual timing of their medication regimen. As an adherence measure, a compliance questionnaire will be collected (CQR5-Compliance Questionnaire for Rheumatology) at baseline and study endpoint. Adherence will also be assessed by the study team at each study visit. In terms of support for this process, at the baseline (T0) treatment allocation visit, the research nurse/officer will guide the participants and/or caregivers through the “CHAMPION-MTX Disease Flare Intervention Support Plan”, which clearly provides contact details, on how to contact the research team and treating rheumatologist, as well as an action plan on how to manage their flares. If participants and/or caregivers become upset or distressed as a result of their participation arrangements, the research nurse/officer will link the participant and/or caregivers to local counselling, psychological support, allied health, community services and/or other appropriate support. If a flare occurs, depending on the severity, the intervention may be ceased and methotrexate restarted, or re-escalated to the previous dose to recapture disease remission. Participants who flare will remain in the trial until they reach the study endpoint (i.e. 12 months from randomisation for Arm 1, and 18 months from randomisation for Arm 2), to monitor post-flare JIA disease re-capture rates.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 21 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria • Age of entry into study less than or equal to 21 years old • Diagnosis, with onset before age of 16 years old, of polyarticular or oligoarticular course of JIA. This would include any of the following subtypes of JIA, as defined by 2001 ILAR classification criteria* o Oligoarticular JIA, including both persistent and extended subcategories o Seronegative polyarticular JIA, with negative RF o Undifferentiated arthritis • Current therapy with methotrexate (MTX) for at least 12 months prior to study enrolment • Stable low or inactive disease for at least 12 months prior to study enrolment as determined by the treating clinician • Clinically inactive disease (CID) or Low Disease activity (LDA) confirmed by cJADAS10 scoring at enrolment, and completion of the 3 months run-in period. • Informed consent from the participant and/or legal guardian to participate in the activities of the study *Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390–2.
Exclusion criteria
Exclusion Criteria • Diagnosis with any of the following forms of JIA, as defined by 2001 ILAR classification criteria: o Seropositive polyarticular JIA, with positive RF o Systemic JIA o Psoriatic arthritis o Enthesitis related arthritis • Active uveitis, and/or receiving treatment for uveitis within the last 12 months • Corticosteroid use within the last 12 months including oral, intra-articular, or intra-ocular or intravenous modes of delivery • Patients who had a b/tsDMARD, or investigational new drug within three months prior to enrolment. • Patients who are primarily on immunomodulating agents for other health conditions, for example for inflammatory bowel disease. • Concurrent medical conditions that in the opinion of the treating paediatric rheumatologist are likely to impact the patient’s safety or interfere with the evaluation of the study outcome (e.g. short life expectancy or planned major surgery). • Neurological and/or psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study. • Despite the use of translation and interpreting services, there is insufficient language understanding and communication skills to provide informed consent and/or understand and participate in study processes.
Outcome results
None listed