Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial

Browse trials for

• Arthritis 3,554
• Arthritis, Juvenile 352

Keywords

• JIA
• maintenance treatment
• medication withdrawal
• withdrawal

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 150 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Study arms

• Active comparator
  Stable treatment

  Stable treatment with methotrexate and TNFi

  Drug: Methotrexate · Drug: TNF Inhibitor

• Experimental
  Methotrexate withdrawal

  Gradual withdrawal of methotrexate

  Drug: Methotrexate

• Experimental
  TNFi withdrawal

  Gradual withdrawal of TNFi

  Drug: TNF Inhibitor

Interventions

• DrugMethotrexate

  Gradual withdrawal of the medication

• DrugTNF Inhibitor

  Gradual withdrawal of the medication

Primary outcomes

1. 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.

   Time frame: 4, 8 and 12 months

2. 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.

   Time frame: 4, 8 and 12 months

Secondary outcomes

1. 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.

   Time frame: 4, 8 and 12 months

2. 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.

   Time frame: 4, 8 and 12 months

3. 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

4. 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

5. 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

6. Concentration of Erythrocyte sedimentation rate (ESR),

   Erythrocyte sedimentation rate (ESR), will be measured at all clinical visits

   Time frame: 4, 8 and 12 months

7. Concentration of C-reactive protein (CRP)

   C-reactive protein (CRP) will be measured at all clinical visits

   Time frame: 4, 8 and 12 months

8. 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

Individual participant data

Plan to share: Yes — A de-identified patient data set can be made available to researchers upon reasonable request.

Supporting information: Study protocol, Sap, Icf