Optimizing treatment strategies for children with Juvenile Idiopathic Arthritis in remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare three different maintenance and step-down treatment strategies for children and adolescents with Juvenile Idiopathic Arthritis (JIA) who are in sustained remission. Participants will be randomized into one of three groups: continued stable treatment with methotrexate and a TNF inhibitor, gradual withdrawal of methotrexate while maintaining the TNF inhibitor, or gradual withdrawal of the TNF inhibitor. The study will assess the differences in disease flare rates and the time to flare occurrence among the groups over a 12-month period. Participants will be monitored every four months to evaluate their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting
• Drammen Hospital
  Drammen, Norway Recruiting
• Hospital of Southern Norway Hospital Trust
  Kristiansand, Norway Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting
• Stavanger University Hospital
  Stavanger, Norway Recruiting
• University Hospital of North Norway
  Tromsø, Norway Recruiting

Study contacts

• Principal investigator: Anna-Birgitte Aga, MD PhD — Oslo University Hospital
• Study coordinator: Siri Opsahl Hetlevik, MD PhD
• Email: siri.opsahl@gmail.com
• Phone: +4795846826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.