Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).
Status:
Recruiting
Trial end date:
2023-11-16
Target enrollment:
Participant gender:
Summary
Inhibitors of tumour necrosis factor (TNFa) reduce inflammation in patients with juvenile
idiopathic arthritis (JIA), but only 20-40 percent achieve a state of no or very little
disease activity. Tailored glucocorticoid joint injections are widely used (usually in
general anaesthesia), but no controlled studies have addressed the effect of this approach.
In Norway there are unique possibilities for early interventions, rapid escalation of
medication and individualised therapy. The investigators aim to find the optimal ways to
increase disease control and improve quality of life for JIA patients.
The hypothesis is that JIA patients starting TNF-inhibitors with added steroid injection of
inflamed joints, will lead to improved outcomes compared to TNF-inhibitors with no joint
injections, and that therapeutic drug monitoring, modern imaging and biologic and clinical
profiling can be utilised to characterise JIA patients with different anti-TNF responses.
MyJIA is a national investigator initiated 48 weeks RCT of JIA patients starting
TNF-inhibitors; 202 JIA patients will be randomised at baseline to A) concomitant
intra-articular glucocorticoid injections versus B) no injections. Primary endpoint is the
rate of sustained remission from weeks 24 to 36. Possible risk factors for not reaching
remission will be analysed including clinical characteristics, drug antibodies/serum
concentrations, patients' reported health status and preferences, molecular signalling (based
on transcriptional, cellular and genetic risk) and synovitis detected by modern imaging
(ultrasound and whole-body MRI).
Patients will be recruited from all Norwegian health regions through an established
collaboration. Unit of Paediatric Rheumatology, Oslo University Hospital, with an extensive
research track in this field, will be the coordinating centre. Broad research cooperation
across disciplines is established. The trial is highly innovative in evaluating treatment
options and strategies to individualise and optimise the efficacy and safety of JIA
treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Haukeland University Hospital Helse Stavanger HF St. Olavs Hospital The Research Council of Norway University Hospital of North Norway