Optimizing Treatment for Patients with Juvenile Idiopathic Arthritis in Sustained Remission: the MOVE-JIA Trial

Last updated: March 19, 2025
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Musculoskeletal Diseases

Joint Injuries

Connective Tissue Diseases

Treatment

TNF Inhibitor

Methotrexate

Clinical Study ID

NCT06653634
2024-513017-12-00
2024-513017-12-00
  • Ages 2-17
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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 anddocumented inactive disease according to Wallace criteria at inclusion, and noactive uveitis for ≥24 months.

  4. Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6months. Weight adjustments permitted.

  5. Capable of giving signed informed consent which includes compliance with therequirements 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

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 ulcusventriculi, and uncontrolled diabetes mellitus.

  3. Use of oral, intra-articular, intramuscular or intravenous corticosteroids due toJIA 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 theinvestigators 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 isunable to comply with the study protocol and procedures.

  9. Unwillingness to use safe contraception for sexually active WOCP.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: TNF Inhibitor
Phase: 4
Study Start date:
October 24, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Haukeland University Hospital

    Bergen, 5009
    Norway

    Active - Recruiting

  • Drammen Hospital

    Drammen, 3004
    Norway

    Active - Recruiting

  • Hospital of Southern Norway Hospital Trust

    Kristiansand, 4615
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 0372
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger, 4019
    Norway

    Active - Recruiting

  • University Hospital of North Norway

    Tromsø, 9019
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

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