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New treatment option for Juvenile Idiopathic Arthritis
Official title Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
ClinicalTrials.gov ID: NCT06653634
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, being studied as a potential treatment for juvenile idiopathic arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Participant must be 2-\<18 years of age at the time of signing the informed consent.
- Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis...
- Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits and documented inactive disease according to Wallace criteria at...
- Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
You likely can't join if
- Chronic widespread pain syndrome
- Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure...
- Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
- Participating in an ongoing clinical assigned by chance study..
- Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
- Language barriers that hamper adherence to the study protocol.
See the full eligibility criteria
- Participant must be 2-\<18 years of age at the time of signing the informed consent.
- Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis (JIA).
- 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.
- Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Male participants: No contraceptive measures necessary.
- Female participants: contraception guidance for women of childbearing potential (WOCP).
- Chronic widespread pain syndrome
- Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
- Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
- Participating in an ongoing clinical assigned by chance study..
- Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
- Language barriers that hamper adherence to the study protocol.
- Pregnancy or breastfeeding.
- Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures.
- Unwillingness to use safe contraception for sexually active WOCP.
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
- Drammen, Norway
- Kristiansand, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway; Drammen, Norway; Kristiansand, Norway; Oslo, Norway; Stavanger, Norway; Tromsø, Norway and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.