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The My-JIA trial

Phase 1
Active, not recruiting
Conditions
Juvenile Idiopathic Arthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
CTIS2023-510118-21-00
Lead Sponsor
Oslo University Hospital HF
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
All
Target Recruitment
188
Inclusion Criteria

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.

Exclusion Criteria

Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus., 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., 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 3 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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To assess if concomitant intra-articular glucocorticoid injections of joints with active arthritis in 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 the efficacy of the two treatment regimens up to 24 weeks of follow-up.;Primary end point(s): The proportion of participants with sustained, inactive disease (according to the Wallace 2011 criteria) and no i.a. or p.o. glucocorticoid use from week 24 to 36.
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s):30% improvement in the paediatric American College of Rheumatology criteria (ACR Pedi 30 improvement) at week 24.
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