Juvenile idiopathic arthritis is characterised by inflamed joints and is the most common chronic rheumatic disease in childhood and adolescence that potentially lead to disability due to joint damage. A prerequisite for the JIA diagnosis is the detection of inflammation of one or more joints (arthritis). Arthritis leads to pain, swelling and stiffness of the affected joints, caused by hypertrophy of the synovial lining of the joint and increased synovial fluid. Untreated, disability may follow.
Conditions
Interventions
Trade Name: Lederspan
Triamcinolone hexacetonide (TH) 20mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRIAMCINOLONE HEXACETONIDE
CAS Number: 5611-51-8
Concentration unit: mg/m
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type of Participant and Disease Characteristics Participants are eligible to be included in the study only if all of the following criteria apply: 1. 1-18 years of age at the time of signing the informed consent. 2. Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA. 3. Clinical indication for starting TNFi treatment according to consensus between at least two physicians. 4. Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure). 5. Juvenile Disease Activity Score (JADAS) >1 at baseline and at least one joint with active arthritis were joint injection is considered. 6. Willing to give written consent (participant = 16, guardians if =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Major comorbidity including significant infectious, neurological, malignant disease, mental disorders or uncontrolled diabetes mellitus. Prior/Concomitant Therapy 2. Used two or more TNFi. 3. Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation. Other Exclusions 4. Presence of hepatitis B surface antigen (HBsAg) at screening. 5. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment. 6. 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. 7. Having received live vaccines less than two weeks prior to randomisation. 8. Drug / alcohol abuse which hampers adherence to the study protocol. 9. Language barriers that hampers adherence to the study protocol. 10. Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if concomitant intra-articular (i.a.) glucocorticoid injections of joints with active arthritis in juvenile idiopathic arthritis (JIA) patients starting Tumour Necrosis Factor (TNF) inhibitor (TNFi) treatment increase the proportion of JIA patients reaching sustained, inactive disease, when compared to the control group not receiving joint injections.;Secondary Objective: - To compare efficacy of treatment regimens up to 24 weeks. - To assess the safety of the intervention and background treatment. - To compare the cost effectiveness of the two treatment regimens - To evaluate the longitudinal disease burden of JIA over 48 weeks - To explore the impact of TNFi concentrations - To explore molecular signatures - To explore the role of modern imaging techniques - To explore composite measures of JIA disease burden as predictor of treatment response.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: At week 24 and week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in disease activity measures and measures of treatment response • Time to inactive disease, flare rates • Changes in patient reported outcomes • Proportion of patients reaching inactive disease • Costs related to changes in health-related quality of life (QOL) • Proportion of patients in disease remission (sustained inactive disease from week 24 to week 48). • Change in patient reported outcome measures • Patient satisfaction and treatment adherence • Longitudinal TNFi drug concentrations, frequency of TNFi drug antibodies compared to measures of disease activity, treatment response and adverse events • Comparison of changes in molecular signatures with measures of disease activity, treatment response. • US and MRI sensitivity to change during therapy • US and MRI sensitivity to detect synovitis • US and MRI as predictors of treatment response . Clinical characteristics (joint patterns, disease activity, patient satisfaction, adherence, health status), molecular signatures (transcriptional, cellular and genetic), and imaging (US and whole-body MRI) assessed synovitis ;Timepoint(s) of evaluation of this end point: Baseline, 6, 12, 24, 36 and 48 weeks. | — |
Countries
Norway
Contacts
Public ContactDepartment of rhuemtology
Oslo University Hospital
Outcome results
None listed