Juvenile Idiopathic ArthritisPhase 4MOVE-JIANCT06653634
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
A Phase 4 study testing Methotrexate and TNF Inhibitor in people with Juvenile Idiopathic Arthritis, run by Oslo University Hospital at 7 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Methotrexate and TNF Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesNorway
- Study dates
- 24 Oct 2024to Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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 randomized 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Norway7 sites, 7 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5009
Maria Karolina Jonsson, MD PhD, maria.karolina.jonsson@helse-bergen.no
- Recruiting
Drammen Hospital
Drammen, 3004
Cathrine Austad, MD, cataus@vestreviken.no
- Recruiting
Hospital of Southern Norway Hospital Trust
Kristiansand, 4615
Hege Høiberg, MD, hege.hoiberg@sshf.no
- Recruiting
Oslo University Hospital
Oslo, 0372
Siri O Hetlevik, MD PhD, +4723070000, siri.opsahl@gmail.com
Anna-Birgitte Aga, MD PhD, +4723070000, anna.birgitte.aga@gmail.com
- Recruiting
Stavanger University Hospital
Stavanger, 4019
Maria Bilstad, MD PhD, maria.bilstad@sus.no
- Recruiting
University Hospital of North Norway
Tromsø, 9019
Ellen Nordal, MD PhD, ellen.berit.nordal@unn.no
- Recruiting
St. Olavs Hospital
Trondheim, 7030
Marite Rygg, MD PhD, marite.rygg@ntnu.no
About this study
Official title: Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial
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?
Read more
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
- Juvenile Idiopathic Arthritis
- Being tested
- Methotrexate, TNF Inhibitor
- Keywords
- JIA, maintenance treatment, medication withdrawal, withdrawal
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Gradual withdrawal of the medication
TNF InhibitorDrug
Gradual withdrawal of the medication
| Study group | Role | What they receive |
|---|---|---|
| Stable treatment | Active comparator | Stable treatment with methotrexate and TNFi Receives: Drug: Methotrexate; Drug: TNF Inhibitor |
| Methotrexate withdrawal | Experimental | Gradual withdrawal of methotrexate Receives: Drug: Methotrexate |
| TNFi withdrawal | Experimental | Gradual withdrawal of TNFi Receives: Drug: TNF Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with disease flare
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment.
*JADAS-27 is a composite measure of juvenile idiopathic arthritis (JIA) disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and erythrocyte sedimentation rate (ESR) normalized to a 0-10 scale.
Measured: 4, 8 and 12 months
Proportion of patients with disease flare between two different withdrawal strategies
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment.
*JADAS-27 is a composite measure of JIA disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and ESR normalized to a 0-10 scale.
Measured: 4, 8 and 12 months
Secondary outcomes (8)
Time to disease flare
JADAS-27, physician's global assessment of diseasae activity, paren't/patient's global assessment, swollen, tender and range of motion joint count (assessed in 71 joints), ESR/CRP, consensus between treating physiciand and patient/parents (uveitis, arthritis on imaging, psoriasis, inflammatory back pain, enthesitis, other; yes/no)
*JADAS-27 is a composite measure of JIA disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components inculded are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and ESR normalized to a 0-10 scale.
Measured: 4, 8 and 12 months
Time to regain inactive disease by the Wallace definition* after flare
JADAS-27, Wallace inactive disease*, physician's global assessment of disease activity, paren't/patient's global assessment, swollen, tender and range of motion joint count (assessed in 71 joints), ESR/CRP, consensus between treating physiciand and patient/parents (uveitis, arthritis on imaging, psoriasis, inflammatory back pain, enthesitis, other; yes/no).
*Wallace inactive disease: No active arthritis, no active uveitis, no morning stiffness >15 minutes, no systemic features (fever/rash/serositis/splenomegaly/lymphadenopathy due to JIA), a physician global assessment of disease activity 0 on a 0-100 scale) and normalization of C-reactive protien (CRP) and ESR.
Measured: 4, 8 and 12 months
Physician global assessment of disease activity
Physician global assessment of disease activity is measured on a 100 mm visual analogue scale (VAS). The anchors of the scale are "very well" to "very poor".
Measured: 4, 8 and 12 months
Disease activity assessed by joint count
In total 68 joints will be evaluated for swelling, 75 joints/joint areas will be evaluated for tenderness and 70 joints/joint areas will be examined for limitation of motion. JADAS10, JADAS27 and JADAS71 and 71-joint count will be computed from this examination
Measured: 4, 8 and 12 months
Patient's/parent's global assessment of well-being
Patient's/parent's global assessment of well-being will be assessed on a 100 mm visual analouge scale.
Measured: 4, 8 and 12 months
Concentration of Erythrocyte sedimentation rate (ESR),
Erythrocyte sedimentation rate (ESR), will be measured at all clinical visits
Measured: 4, 8 and 12 months
Concentration of C-reactive protein (CRP)
C-reactive protein (CRP) will be measured at all clinical visits
Measured: 4, 8 and 12 months
Numbers and type of adverse events (AE)
Assessment of AE, serious AE and suspected unexpected serious adverse reactions
Measured: 4, 8 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start24 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, South-Eastern Norway Regional Health Authority, Remedy
- Responsible party
- Principal investigator, Anna-Birgitte Aga, Oslo University Hospital
- Investigators
- Anna-Birgitte Aga, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653634
- Sponsor's protocol ID
- 2024-513017-12-00
- Other IDs
- 2024-513017-12-00
- Acronym
- MOVE-JIA
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified patient data set can be made available to researchers upon reasonable request.
Publications
Hetlevik SO, Lilleby V, Pesonen M, Nordal E, Rygg M, Austad C, Jonsson MK, Bilstad M, Hoiberg HK, Sande NK, Flato B, Lillegraven S, Haavardsholm EA, Ramanan AV, Molberg O, Boyesen P, Aga AB. 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. Trials. 2026 Feb 17;27(1):229. doi: 10.1186/s13063-026-09539-0.
PubMed 41703606
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial
- ClinicalTrials.gov ID
- NCT06653634
- Acronym / sponsor ID
- MOVE-JIA / 2024-513017-12-00
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA, maintenance treatment, medication withdrawal, withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, South-Eastern Norway Regional Health Authority, Remedy
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Stable treatment | Active comparator | Drug: Methotrexate, Drug: TNF InhibitorStable treatment with methotrexate and TNFi |
| Methotrexate withdrawal | Experimental | Drug: MethotrexateGradual withdrawal of methotrexate |
| TNFi withdrawal | Experimental | Drug: TNF InhibitorGradual withdrawal of TNFi |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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 randomized study..
- Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateGradual withdrawal of the medication | Drug | Methotrexate withdrawal, Stable treatment |
| TNF InhibitorGradual withdrawal of the medication | Drug | Stable treatment, TNFi withdrawal |
Primary outcome
Proportion of patients with disease flare
Time frame: 4, 8 and 12 months
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment. *JADAS-27 is a composite measure of juvenile idiopathic arthritis (JIA) disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and erythrocyte sedimentation rate (ESR) normalized to a 0-10 scale.
Proportion of patients with disease flare between two different withdrawal strategies
Time frame: 4, 8 and 12 months
Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment. *JADAS-27 is a composite measure of JIA disease activity, calculated as a sum of scores from four components giving a score of 0-57. The components included are physician global assessment of disease activity, parent/patient's global assessment of well-being, active joint count of 27 joints and ESR normalized to a 0-10 scale.
8 secondary outcomes
Time to disease flare
Time frame: 4, 8 and 12 months
Time to regain inactive disease by the Wallace definition* after flare
Time frame: 4, 8 and 12 months
Physician global assessment of disease activity
Time frame: 4, 8 and 12 months
Disease activity assessed by joint count
Time frame: 4, 8 and 12 months
Patient's/parent's global assessment of well-being
Time frame: 4, 8 and 12 months
Concentration of Erythrocyte sedimentation rate (ESR),
Time frame: 4, 8 and 12 months
Concentration of C-reactive protein (CRP)
Time frame: 4, 8 and 12 months
Numbers and type of adverse events (AE)
Time frame: 4, 8 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 41703606Hetlevik SO, Lilleby V, Pesonen M, Nordal E, Rygg M, Austad C, Jonsson MK, Bilstad M, Hoiberg HK, Sande NK, Flato B, Lillegraven S, Haavardsholm EA, Ramanan AV, Molberg O, Boyesen P, Aga AB. 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. Trials. 2026 Feb 17;27(1):229. doi: 10.1186/s13063-026-09539-0.
- Individual participant dataSharing planned: Yes. A de-identified patient data set can be made available to researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna-Birgitte Aga, MD PhD principal investigator
Oslo University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and TNF Inhibitor in people with Juvenile Idiopathic Arthritis, run by Oslo University Hospital at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siri Opsahl Hetlevik, MD PhD (+4795846826, siri.opsahl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with disease flare (time frame: 4, 8 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.