Personalised treatment of my juvenile arthritis
- Conditions
- 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.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-000889-38-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 202
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 < 16 years of age, both participants and guardians if 16-18) and comply with the requirements of the study protocol.
Contraceptive use by men or women
Male participants: No measures necessary.
Female participants: Contraception Guidance for WOCBP see Appendix 4 (Section 10.4.2).
Informed Consent
7.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 202
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method