Haukeland University Hospital
RecruitingBergen, 5009, Norway
Site contacts (1)
Maria Karolina Jonsson, MD PhDContactEmail: maria.karolina.jonsson@helse-bergen.no
CLINICAL STUDY · NCT06653634
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
RecruitingPhase 4Interventional
Sponsored by Oslo University Hospital
- Condition
- Juvenile Idiopathic Arthritis
- Study locations
- 7 reported sites
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
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.
* 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.
Full 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
PARTICIPATION
Who may participate
- Minimum age
- 2 Years
- Maximum age
- 17 Years
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion criteria
Inclusion Criteria:
1. Participant must be 2-\<18 years of age at the time of signing the informed consent.
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:
1. Chronic widespread pain syndrome
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.
1. Participant must be 2-\<18 years of age at the time of signing the informed consent.
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:
1. Chronic widespread pain syndrome
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.
NEAR YOU
Study locations worldwide
7 sitesCheck the individual site’s status and contact the listed study team for current availability.
7 sites shown
Drammen Hospital
RecruitingDrammen, 3004, Norway
Site contacts (1)
Cathrine Austad, MDContactEmail: cataus@vestreviken.no
Hospital of Southern Norway Hospital Trust
RecruitingKristiansand, 4615, Norway
Site contacts (1)
Hege Høiberg, MDContactEmail: hege.hoiberg@sshf.no
Oslo University Hospital
RecruitingOslo, 0372, Norway
Site contacts (3)
Siri O Hetlevik, MD PhDPrincipal investigator
Stavanger University Hospital
RecruitingStavanger, 4019, Norway
Site contacts (1)
Maria Bilstad, MD PhDContactEmail: maria.bilstad@sus.no
University Hospital of North Norway
RecruitingTromsø, 9019, Norway
Site contacts (1)
Ellen Nordal, MD PhDContactEmail: ellen.berit.nordal@unn.no
St. Olavs Hospital
RecruitingTrondheim, 7030, Norway
Site contacts (1)
Marite Rygg, MD PhDContactEmail: marite.rygg@ntnu.no
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
Interventions
Methotrexate
Gradual withdrawal of the medication
Study groups: Methotrexate withdrawal, Stable treatment
TNF Inhibitor
Gradual withdrawal of the medication
Study groups: Stable treatment, TNFi withdrawal
Study groups
Stable treatment
Stable treatment with methotrexate and TNFi
Interventions: Drug: Methotrexate, Drug: TNF Inhibitor
Methotrexate withdrawal
Gradual withdrawal of methotrexate
Interventions: Drug: Methotrexate
TNFi withdrawal
Gradual withdrawal of TNFi
Interventions: Drug: TNF Inhibitor
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomized
- Study model
- Parallel
- Masking
- None (open label)
- Enrolment
- 150 participants · Estimated
Study model details
Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 24 Oct 2024 · Actual
- Primary completion
- Dec 2027 · Estimated
- Study completion
- Dec 2029 · Estimated
- First registered
- 22 Oct 2024 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (2)
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.
\*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.
Time frame: 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.
\*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.
Time frame: 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.
\*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.
Time frame: 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.
\*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.
Time frame: 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".
Time frame: 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
Time frame: 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.
Time frame: 4, 8 and 12 months
Concentration of Erythrocyte sedimentation rate (ESR),
Erythrocyte sedimentation rate (ESR), will be measured at all clinical visits
Time frame: 4, 8 and 12 months
Concentration of C-reactive protein (CRP)
C-reactive protein (CRP) will be measured at all clinical visits
Time frame: 4, 8 and 12 months
Numbers and type of adverse events (AE)
Assessment of AE, serious AE and suspected unexpected serious adverse reactions
Time frame: 4, 8 and 12 months
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- Other
- Collaborators
- The Research Council of Norway, South-Eastern Norway Regional Health Authority, Remedy
- Organisation study ID
- 2024-513017-12-00
Central study contacts
Study officials
Anna-Birgitte Aga, MD PhDPrincipal investigator · Oslo University Hospital
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.
Publications (1)
- 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 ↗