Clinical trial NCT06653634: Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
Official title: Optimizing Treatment for Children and Adolescents With Juvenile Idiopathic Arthritis in Sustained Remission: a Comparison of Three Treatment Strategies. The MOVE-JIA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
maintenance treatment
medication withdrawal
withdrawal
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: South-Eastern Norway Regional Health Authority
name: Remedy
First posted: 2024-10-22
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Researcher initiated, randomized controlled, 3-arm, parallel group, national, multicenter clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 and documented inactive disease according to Wallace criteria at inclusion, and no active uveitis for ≥24 months.
4. Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
5. Capable of giving signed informed consent which includes compliance with the requirements 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 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 ulcus ventriculi, and uncontrolled diabetes mellitus.
3. Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA 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 the investigators 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 is unable to comply with the study protocol and procedures.
9. Unwillingness to use safe contraception for sexually active WOCP.

Primary outcomes:
measure: Proportion of patients with disease flare
timeFrame: 4, 8 and 12 months
measure: Proportion of patients with disease flare between two different withdrawal strategies
timeFrame: 4, 8 and 12 months
Secondary outcomes:
measure: Time to disease flare
timeFrame: 4, 8 and 12 months
measure: Time to regain inactive disease by the Wallace definition* after flare
timeFrame: 4, 8 and 12 months
measure: Physician global assessment of disease activity
timeFrame: 4, 8 and 12 months
measure: Disease activity assessed by joint count
timeFrame: 4, 8 and 12 months
measure: Patient's/parent's global assessment of well-being
timeFrame: 4, 8 and 12 months
measure: Concentration of Erythrocyte sedimentation rate (ESR),
timeFrame: 4, 8 and 12 months
measure: Concentration of C-reactive protein (CRP)
timeFrame: 4, 8 and 12 months
measure: Numbers and type of adverse events (AE)
timeFrame: 4, 8 and 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Drammen Hospital
city: Kristiansand
country: Norway
facility: Hospital of Southern Norway Hospital Trust
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anna-Birgitte Aga, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: