Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): the MyJIA Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 5
- 主要终点
- The proportion of JIA participants with sustained inactive disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The individual who evaluates joints clinically will be blinded to study information.
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-18 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.
- •Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure).
- •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.
排除标准
- •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.
- •Other Exclusions
- •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.
研究组 & 干预措施
Intervention
Intra-articular corticosteroid injections into active joints
干预措施: Triamcinolone Hexacetonide 20 MG/ML (Drug)
结局指标
主要结局
The proportion of JIA participants with sustained inactive disease
时间窗: Week 24 to week 36.
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.
次要结局
- Time to inactive disease(Baseline to 48 weeks)
- Change from baseline in arthritis-related pain severity as measured by pain VAS item(48 weeks)
- Juvenile arthritis disease activity score (JADAS)(Baseline to week 6, 12 and 24.)
- 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.)
- Proportion of Participants with Minimal Disease Activity(Week 26 to 48)
研究者
Pernille Helen Bøyesen
MD PhD
Oslo University Hospital