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

NCT04614311 | Completed Phase 4

• 1 other identifier: 171224
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proportion of JIA participants with sustained inactive disease

  The proportion of participants with sustained, inactive disease from week 24 to week 36. Inactive disease is defined according the 2011 Wallace criteria: * No active arthritis† * Physician global assessment of disease activity score normal (0) * Erythrocyte sedimentation rate (ESR) within normal range * Morning stiffness ≤ 15 minutes * No active uveitis * No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA In addition, no use of any i.a. or p.o. corticosteroids from week 20 to week 36. †Active arthritis according to the ACR definition: 1. a joint with swelling not due to bony enlargement OR, if no swelling is present 2. limitation of motion accompanied by either pain on motion and/or tenderness.

  Week 24 to week 36.

Secondary Outcomes (6)

• The proportion of participants with ACR pedi 30% response

  Baseline to week 6,12 and 24

• The proportion of participants with ACR pedi 50,70 and 90% response

  Baseline to week 6, 12 and 24.

• Juvenile arthritis disease activity score (JADAS)

  Baseline to week 6, 12 and 24.

• Time to inactive disease

  Baseline to 48 weeks

• Proportion of Participants with Minimal Disease Activity

  Week 26 to 48

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intra-articular corticosteroid injections into active joints

Drug: Triamcinolone Hexacetonide 20 MG/ML

Comparator

NO INTERVENTION

No intra-articular injections

Interventions

Triamcinolone Hexacetonide 20 MG/ML DRUG

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

Also known as: Lederspan

Intervention

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age at the time of signing the informed consent.
• Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA.
• Clinical indication for starting TNFi treatment according to consensus between at least two physicians.
• Juvenile Disease Activity Score (JADAS) \>1 at baseline and at least one joint with active arthritis were joint injection is considered.
• Willing to give written consent (participant ≥ 16, guardians if \< 16 years of age, both participants and guardians if 16-18) and comply with the requirements of the study protocol.

You may not qualify if:

• Medical Conditions
• Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
• Prior/Concomitant Therapy
• Used two or more TNFi.
• Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation.
• Known hypersensitivity to Triamcinolone hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol).
• Concomitant therapy with CYP3A-inhibitors or digitalis glycosides.
• Known inherited fructose intolerance
• Presence of hepatitis B surface antigen (HBsAg) at screening.
• Positive hepatitis C antibody test result at screening or within 12 months prior to starting study treatment.
• Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (front), and TB testing. The choice of TB tests will be made by the investigator according to local licensing and standard of care.
• Having received live vaccines less than two weeks prior to randomisation.
• Drug / alcohol abuse which hampers adherence to the study protocol.
• Language barriers that hampers adherence to the study protocol.
• Pregnancy or breast-feeding.

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Research Council of Norway: collaborator
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• Helse Stavanger HF: collaborator

Study Sites (5)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

St Olavs Hospital

Trondheim, Trønderlag, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital of North Norway

Tromsø, 9019, Norway

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pernille H Bøyesen, MD PhD

  Oslo University Hospital

  STUDY DIRECTOR

• Anna-Birgitte Aga, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Berit Flatø, Prof

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates joints clinically will be blinded to study information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Parallel intervention were participants are assigned to either the control group or intervention group.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: December 1, 2020
• Primary Completion: November 7, 2024
• Study Completion: February 6, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)