Phase
Condition
Musculoskeletal Diseases
Joint Injuries
Connective Tissue Diseases
Treatment
TNF Inhibitor
Methotrexate
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 2-<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 Juvenile Idiopathic Arthritis (JIA).
Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits anddocumented inactive disease according to Wallace criteria at inclusion, and noactive uveitis for ≥24 months.
Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6months. Weight adjustments permitted.
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF).
Male participants: No contraceptive measures necessary.
Female participants: contraception guidance for women of childbearing potential (WOCP).
Exclusion
Exclusion Criteria:
Chronic widespread pain syndrome
Major comorbidity including uncontrolled infectious, neurological or mental disease,malignant disease, severe heart failure, severe renal failure, active ulcusventriculi, and uncontrolled diabetes mellitus.
Use of oral, intra-articular, intramuscular or intravenous corticosteroids due toJIA less than 12 months prior to randomization.
Participating in an ongoing clinical randomized study..
Drug/alcohol abuse which hampers adherence to the study protocol as based on theinvestigators judgement.
Language barriers that hamper adherence to the study protocol.
Pregnancy or breastfeeding.
Any condition that in the view of the investigator would suggest that the patient isunable to comply with the study protocol and procedures.
Unwillingness to use safe contraception for sexually active WOCP.
Study Design
Connect with a study center
Haukeland University Hospital
Bergen, 5009
NorwayActive - Recruiting
Drammen Hospital
Drammen, 3004
NorwayActive - Recruiting
Hospital of Southern Norway Hospital Trust
Kristiansand, 4615
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 0372
NorwayActive - Recruiting
Stavanger University Hospital
Stavanger, 4019
NorwayActive - Recruiting
University Hospital of North Norway
Tromsø, 9019
NorwayActive - Recruiting
St. Olavs Hospital
Trondheim, 7030
NorwayActive - Recruiting
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