Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

DRUG

Triamcinolone Hexacetonide 20 MG/ML

JIA patients (age 1-18 years) starting TNFi treatment randomised to intervention will receive treatment with intra articular glucocorticoids (triamcinolone hexacetonide) injections in inflamed joints

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Pernille H Bøyesen, MD PhD · Oslo University Hospital

• Anna-Birgitte Aga, MD PhD · Oslo University Hospital

• Berit Flatø, Prof · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2024-11-07

Completion

2025-02-06

Countries

• Norway

Study Locations