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NCT Number: NCT06653634

Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: 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?

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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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

methotrexate

Drug

Gradual withdrawal of the medication

TNF Inhibitor

Drug

Gradual withdrawal of the medication

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Time to disease flare

    Time frame: 4, 8 and 12 months

    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.

  2. Time to regain inactive disease by the Wallace definition* after flare

    Time frame: 4, 8 and 12 months

    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.

  3. Physician global assessment of disease activity

    Time frame: 4, 8 and 12 months

    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. Disease activity assessed by joint count

    Time frame: 4, 8 and 12 months

    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

  5. Patient's/parent's global assessment of well-being

    Time frame: 4, 8 and 12 months

    Patient's/parent's global assessment of well-being will be assessed on a 100 mm visual analouge scale.

  6. Concentration of Erythrocyte sedimentation rate (ESR),

    Time frame: 4, 8 and 12 months

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

  7. Concentration of C-reactive protein (CRP)

    Time frame: 4, 8 and 12 months

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

  8. Numbers and type of adverse events (AE)

    Time frame: 4, 8 and 12 months

    Assessment of AE, serious AE and suspected unexpected serious adverse reactions

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Birgitte Aga, MD PhD

CONTACT

[email protected]

+4740470692

Siri Opsahl Hetlevik, MD PhD

CONTACT

[email protected]

+4795846826

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Remedy
  • South-Eastern Norway Regional Health Authority
  • The Research Council of Norway

Registry information

Official study title

Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial

Acronym: MOVE-JIA

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 22, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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