Actively Recruiting
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
Led by Oslo University Hospital · Updated on 2025-03-24
150
Participants Needed
7
Research Sites
266 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
T
The Research Council of Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is between 2 and less than 18 years old at the time of signing informed consent
- Diagnosed with non-systemic Juvenile Idiopathic Arthritis according to ILAR classification
- Inactive disease for at least 12 months confirmed at two consecutive visits and inactive disease by Wallace criteria at inclusion
- No active uveitis for at least 24 months
- Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor for at least 6 months with allowed weight adjustments
- Able to give signed informed consent and comply with study requirements
- Male participants require no contraceptive measures
- Female participants of childbearing potential must follow contraception guidance
You will not qualify if you...
- Having chronic widespread pain syndrome
- Major uncontrolled comorbidities such as infectious, neurological, mental disease, malignancy, severe heart or renal failure, active stomach ulcers, or uncontrolled diabetes
- Use of corticosteroids for JIA within 12 months before randomization
- Currently participating in another randomized clinical trial
- Drug or alcohol abuse affecting study adherence
- Language barriers affecting study adherence
- Pregnancy or breastfeeding
- Any condition that may prevent compliance with study procedures
- Unwillingness to use safe contraception for sexually active women of childbearing potential
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Haukeland University Hospital
Bergen, Norway, 5009
Actively Recruiting
2
Drammen Hospital
Drammen, Norway, 3004
Actively Recruiting
3
Hospital of Southern Norway Hospital Trust
Kristiansand, Norway, 4615
Actively Recruiting
4
Oslo University Hospital
Oslo, Norway, 0372
Actively Recruiting
5
Stavanger University Hospital
Stavanger, Norway, 4019
Actively Recruiting
6
University Hospital of North Norway
Tromsø, Norway, 9019
Actively Recruiting
7
St. Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
Research Team
S
Siri Opsahl Hetlevik, MD PhD
CONTACT
A
Anna-Birgitte Aga, MD PhD
CONTACT
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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