Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial

Launched by OSLO UNIVERSITY HOSPITAL · Oct 20, 2024

Keywords

ClinConnect Summary

The MOVE-JIA Trial is a clinical study designed to find the best way to manage treatment for children and teenagers with Juvenile Idiopathic Arthritis (JIA) who have been in remission for a while. The trial will compare three different approaches to see how well they work in preventing disease flares, which are periods when symptoms come back. Some participants will continue with their current medication, while others will gradually reduce their medication. The main goals are to see if the chance of having a flare differs between the groups and how quickly flares can happen.

To be eligible for this study, participants need to be between 2 and 18 years old and have had no active symptoms for at least 12 months. They should also be on a stable treatment plan that includes specific medications for at least 6 months. Throughout the study, participants will have check-ups every four months, and they can come in for extra visits if they notice their symptoms getting worse. If a flare occurs, their original medications will be restarted. This study is important because it could help doctors understand the best ways to manage JIA in children and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be 2-\<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 Juvenile Idiopathic Arthritis (JIA).
• • 3. Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits and documented inactive disease according to Wallace criteria at inclusion, and no active uveitis for ≥24 months.
• • 4. Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
• • 5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
• • 6. Male participants: No contraceptive measures necessary.
• • 7. Female participants: contraception guidance for women of childbearing potential (WOCP).
• Exclusion Criteria:
• • 1. Chronic widespread pain syndrome
• • 2. Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
• • 3. Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
• • 4. Participating in an ongoing clinical randomized study..
• • 5. Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
• • 6. Language barriers that hamper adherence to the study protocol.
• • 7. Pregnancy or breastfeeding.
• • 8. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures.
• • 9. Unwillingness to use safe contraception for sexually active WOCP.