Optimizing treatment strategies for children with Juvenile Idiopathic Arthritis in remission
Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial
This study is testing three different ways to adjust treatment for children with Juvenile Idiopathic Arthritis who are doing well to see which method keeps them healthy the longest.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 7 sites (Bergen and 6 other locations) |
| Trial ID | NCT06653634 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare three different maintenance and step-down treatment strategies for children and adolescents with Juvenile Idiopathic Arthritis (JIA) who are in sustained remission. Participants will be randomized into one of three groups: continued stable treatment with methotrexate and a TNF inhibitor, gradual withdrawal of methotrexate while maintaining the TNF inhibitor, or gradual withdrawal of the TNF inhibitor. The study will assess the differences in disease flare rates and the time to flare occurrence among the groups over a 12-month period. Participants will be monitored every four months to evaluate their condition.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2 to 18 years with a diagnosis of non-systemic Juvenile Idiopathic Arthritis in sustained remission.
Not a fit: Patients with chronic widespread pain syndrome or major comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could help identify the most effective treatment strategy for maintaining remission in children with JIA, potentially reducing medication burden.
How similar studies have performed: Other studies have explored treatment strategies for JIA, but this specific approach of comparing withdrawal strategies is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bergen and 6 other locations
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Drammen Hospital — Drammen, Norway (Recruiting)
- Hospital of Southern Norway Hospital Trust — Kristiansand, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Anna-Birgitte Aga, MD PhD — Oslo University Hospital
- Study coordinator: Siri Opsahl Hetlevik, MD PhD
- Email: siri.opsahl@gmail.com
- Phone: +4795846826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.