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

NCT06653634 | Recruiting Phase 4

• 1 other identifier: 2024-513017-12-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA; maintenance treatment; medication withdrawal; withdrawal

Outcome Measures

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.

  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

Secondary Outcomes (8)

• Time to disease flare

  4, 8 and 12 months

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

  4, 8 and 12 months

• Physician global assessment of disease activity

  4, 8 and 12 months

• Disease activity assessed by joint count

  4, 8 and 12 months

• Patient's/parent's global assessment of well-being

  4, 8 and 12 months

Study Arms (3)

Stable treatment

ACTIVE COMPARATOR

Stable treatment with methotrexate and TNFi

Drug: Methotrexate; Drug: TNF Inhibitor

Methotrexate withdrawal

EXPERIMENTAL

Gradual withdrawal of methotrexate

Drug: Methotrexate

TNFi withdrawal

EXPERIMENTAL

Gradual withdrawal of TNFi

Drug: TNF Inhibitor

Interventions

Methotrexate DRUG

Gradual withdrawal of the medication

Methotrexate withdrawal; Stable treatment

TNF Inhibitor DRUG

Gradual withdrawal of the medication

Stable treatment; TNFi withdrawal

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Research Council of Norway: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• Remedy: collaborator

Study Sites (7)

Haukeland University Hospital

Bergen, 5009, Norway

RECRUITING

Drammen Hospital

Drammen, 3004, Norway

RECRUITING

Hospital of Southern Norway Hospital Trust

Kristiansand, 4615, Norway

RECRUITING

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

Stavanger University Hospital

Stavanger, 4019, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9019, Norway

RECRUITING

St. Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Methotrexate; Tumor Necrosis Factor Inhibitors

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Inflammatory Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anna-Birgitte Aga, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siri Opsahl Hetlevik, MD PhD

CONTACT

+4795846826; siri.opsahl@gmail.com

Anna-Birgitte Aga, MD PhD

CONTACT

+4740470692; anna.birgitte.aga@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 10 years
• Access Criteria: 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.

Locations

NO (7)