NCT06653634 Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
| NCT ID | NCT06653634 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oslo University Hospital |
| Condition | Juvenile Idiopathic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2024-10-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare three different maintenance and step-down treatment strategies in children and adolescents with juvenile idiopathic arthritis in sustained remission. The main questions it aims to answer are: * Is the proportion of study participants with a disease flare different between each of the two drug withdrawal arms and the stable treatment arm during 12 months? * Does the proportion of study participants with a disease flare differ between the two drug withdrawal arms during 12 months? * How long time does it take before a disease flare occurs, and how long does it take before disease remission is reestablished for participants in the different treatment arms? Participants will be randomized to either A) continued stable treatment with methotrexate and tumor-necrosis alpha inhibitor (TNFi); B) gradual withdrawal of methotrexate while continued stable dose TNFi; or C) gradual withdrawal of TNFi. Participants will be examined every 4 month, and with extra visits if they experience increased symptoms or suspect a disease flare. If a flare occurs, the medications received at study inclusion will be restarted.
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.
Contact & Investigator
Anna-Birgitte Aga, MD PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06653634 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06653634 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06653634 currently recruiting?
Yes, NCT06653634 is actively recruiting participants. Contact the research team at siri.opsahl@gmail.com for enrollment information.
Where is the NCT06653634 trial being conducted?
This trial is being conducted at Bergen, Norway, Drammen, Norway, Kristiansand, Norway, Oslo, Norway and 3 additional locations.
Who is sponsoring the NCT06653634 clinical trial?
NCT06653634 is sponsored by Oslo University Hospital. The principal investigator is Anna-Birgitte Aga, MD PhD at Oslo University Hospital. The trial plans to enroll 150 participants.