Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
NCT ID: NCT06653634
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2024-10-24
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
NCT00642460
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
NCT01844518
Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
NCT01015547
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
NCT06654882
Juvenile Idiopathic Arthritis (JIA) Registry
NCT00783510
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stable treatment
Stable treatment with methotrexate and TNFi
Methotrexate
Gradual withdrawal of the medication
TNF Inhibitor
Gradual withdrawal of the medication
Methotrexate withdrawal
Gradual withdrawal of methotrexate
Methotrexate
Gradual withdrawal of the medication
TNFi withdrawal
Gradual withdrawal of TNFi
TNF Inhibitor
Gradual withdrawal of the medication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
Gradual withdrawal of the medication
TNF Inhibitor
Gradual withdrawal of the medication
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Research Council of Norway
OTHER
South-Eastern Norway Regional Health Authority
OTHER
Remedy
INDUSTRY
Oslo University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anna-Birgitte Aga
Coordinating Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anna-Birgitte Aga, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland University Hospital
Bergen, , Norway
Drammen Hospital
Drammen, , Norway
Hospital of Southern Norway Hospital Trust
Kristiansand, , Norway
Oslo University Hospital
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital of North Norway
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513017-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-513017-12-00
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.