Comparing Three Treatment Approaches for Children and Adolescents With Juvenile Idiopathic Arthritis in Remission The MOVE-JIA Trial
Led by Oslo University Hospital · Updated on 2025-03-24
150
Participants Needed
7
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing three different treatment strategies for children and adolescents with juvenile idiopathic arthritis JIA who are in sustained remission. The study aims to find out if the rate of disease flare differs between continuing stable treatment and two types of drug withdrawal over 12 months. It also looks at the timing of flare occurrence and how long it takes to regain remission after a flare.
Participants will be randomly assigned to one of three groups continued stable treatment with methotrexate and a tumor necrosis factor inhibitor TNFi, gradual withdrawal of methotrexate while maintaining TNFi, or gradual withdrawal of TNFi. The study involves regular visits every 4 months, with extra visits if symptoms suggest a flare. If a flare occurs, the original medications will be restarted.
During the study, participants will undergo assessments every 4 months, including evaluations of disease activity by joint counts and physician global assessments. Laboratory tests such as erythrocyte sedimentation rate ESR and C-reactive protein CRP levels will be measured. Patient or parent assessments of well-being and monitoring for adverse events will also be conducted. The study lasts for at least 12 months of follow-up to track flares, disease activity, and safety.
CONDITIONS
Brief Title
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
Research Team
S
Siri Opsahl Hetlevik, MD PhD
A
Anna-Birgitte Aga, MD PhD
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Participant is 2 to less than 18 years old at consent
Diagnosed with non-systemic Juvenile Idiopathic Arthritis according to ILAR criteria
Inactive disease for at least 12 months confirmed at two visits and at inclusion by Wallace criteria
No active uveitis for at least 24 months
Stable treatment with methotrexate and TNF inhibitor for at least 6 months
Able to give signed informed consent and comply with study requirements
Male participants do not require contraception
Female participants of childbearing potential must follow contraception guidance
You will not qualify if you...
Chronic widespread pain syndrome
Major uncontrolled diseases such as infections, neurological or mental disease, cancer, severe heart or kidney failure, stomach ulcers, or uncontrolled diabetes
Use of corticosteroids for JIA within 12 months before randomization
Participation in another ongoing randomized clinical study
Drug or alcohol abuse affecting study adherence
Language barriers affecting study adherence
Pregnancy or breastfeeding
Any condition preventing compliance with study procedures
Unwillingness to use safe contraception for sexually active females of childbearing potential
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive either stable treatment or gradual withdrawal of methotrexate or TNF inhibitor to manage Juvenile Idiopathic Arthritis in sustained remission.
Visits at 4, 8, and 12 months for assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Comparing Three Treatment Approaches for Children and Adolescents With Juvenile Idiopathic Arthritis in Remission The MOVE-JIA Trial
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Published Research Related To This Trial
Moving towards optimized treatment for children and adolescents with juvenile idiopathic arthritis in sustained remission randomized to continue stable treatment, methotrexate withdrawal or tumor necrosis factor inhibitor withdrawal: study protocol for the Norwegian multi-center MOVE-JIA trial.
Siri Opsahl Hetlevik, Vibke Lilleby, Maiju Pesonen...