PREVENT JIA-Study: Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)

Not Applicable

Completed

• Conditions: Musculoskeletal Diseases; Juvenile arthritis; Juvenile idiopathic arthritis

• Registration Number: ISRCTN69963079
• Lead Sponsor: Interdisciplinary Center For Clinical Research Muenster (Interdisziplinäres Zentrum für Klinische Forschung) (Germany)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35260388/ (added 14/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-21
• Study Completion: 2019-08-31
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Patients with polyarticular course of any JIA subcategory will be included at first confirmation of remission on medication, i.e. after clinically documented inactive disease for 6 months. At the time remission is documented, patients may be only on non-steroidal anti-inflammatory drugs (NSAIDs) plus DMARDs and/or biologics at a stable dose. Steroids must have beenwithdrawn at least 1 month before remission is documented. Intraarticular joint injections should not have been performed 6 months before remission is documented.

Exclusion Criteria

Patients with persistent oligoarthritis subtype or systemic JIA having systemic features (within 1 year prior to inclusion) are excluded. In addition, patients may not have received treatment with steroids in the month before remission is first documented or treatment with intraarticular joint injections etc. in the 6 months before remission is first documented. Patient with a history of uveitis or macrophage activation syndrome are excluded. Patients may also not be included if withdrawal of any biological drug has ever been unsuccessful in the past.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free interval, i.e. the time to first flare after therapy withdrawal

Secondary Outcome Measures

Name	Time	Method
The combined flare rate of all patients in the study will be compared to cohorts from previous studies providing robust data for a flare rate of 45%-50% after random withdrawal of therapy shown independently in several studies. As it can be expected from our trial published in JAMA and ARD that the flare rate will be only around 25%-30% with the stratified approach, we cannot withhold the chance of this superior approach from the patients included. The choice of comparisons was established in previous studies. The rationale for the biomarker to be tested, the units, and the cut offs at 175 ng/ml (S100A12) and 0.3 mg/dl (hsCRP) were established in published work.