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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Drammen Hospital
RECRUITING
Drammen
Hospital of Southern Norway Hospital Trust
RECRUITING
Kristiansand
Oslo University Hospital
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
University Hospital of North Norway
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Siri Opsahl Hetlevik, MD PhD
siri.opsahl@gmail.com
+4795846826
Backup
Anna-Birgitte Aga, MD PhD
anna.birgitte.aga@gmail.com
+4740470692
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2029-12
Participants
Target number of participants: 150
Treatments
Active_comparator: Stable treatment
Stable treatment with methotrexate and TNFi
Experimental: Methotrexate withdrawal
Gradual withdrawal of methotrexate
Experimental: TNFi withdrawal
Gradual withdrawal of TNFi
Sponsors
Collaborators: The Research Council of Norway, South-Eastern Norway Regional Health Authority, Remedy
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

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