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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513017-12-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| South-Eastern Norway Regional Health Authority | OTHER |
| Remedy | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stable treatment | Active Comparator | Stable treatment with methotrexate and TNFi |
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| Methotrexate withdrawal | Experimental | Gradual withdrawal of methotrexate |
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| TNFi withdrawal | Experimental | Gradual withdrawal of TNFi |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Gradual withdrawal of the medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4, 8 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siri Opsahl Hetlevik, MD PhD | Contact | +4795846826 | siri.opsahl@gmail.com | |
| Anna-Birgitte Aga, MD PhD | Contact | +4740470692 | anna.birgitte.aga@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna-Birgitte Aga, MD PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | 5009 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41703606 | Derived | 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. |
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A de-identified patient data set can be made available to researchers upon reasonable request.
10 years
The data will only be made available after submission of a project plan outlining a reasonable request and any proposed analyses, and will have to be approved by the the MOVE-JIA steering group. Project proposals can be submitted to the corresponding author. Data sharing will have to follow appropriate regulations.
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000079424 | Tumor Necrosis Factor Inhibitors |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial
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| TNF Inhibitor | Drug | Gradual withdrawal of the medication |
|
| 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. | 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". | 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 | 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. | 4, 8 and 12 months |
| Concentration of Erythrocyte sedimentation rate (ESR), | Erythrocyte sedimentation rate (ESR), will be measured at all clinical visits | 4, 8 and 12 months |
| Concentration of C-reactive protein (CRP) | C-reactive protein (CRP) will be measured at all clinical visits | 4, 8 and 12 months |
| Numbers and type of adverse events (AE) | Assessment of AE, serious AE and suspected unexpected serious adverse reactions | 4, 8 and 12 months |
| Drammen Hospital | Recruiting | Drammen | 3004 | Norway |
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| Hospital of Southern Norway Hospital Trust | Recruiting | Kristiansand | 4615 | Norway |
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| Oslo University Hospital | Recruiting | Oslo | 0372 | Norway |
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| Stavanger University Hospital | Recruiting | Stavanger | 4019 | Norway |
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| University Hospital of North Norway | Recruiting | Tromsø | 9019 | Norway |
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| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |