What is the best way to plan a 12-month clinical drug trial in JIA associated uveitis?

Abstract

INTRODUCTION: Juvenile idiopathic arthritis associated anterior uveitis (JIA-U) is the most common extraarticular manifestation of JIA. There are no published proposed criteria or outcome measures for a 12-month clinical trial for JIA-U. AREAS COVERED: Our expert group, the Multinational Interdisciplinary Working Group for Uveitis in Childhood (MIWGUC), reviewed the previous trials, the quality-of-life instruments, biomarkers, and the patient perspective. Based on an expert consensus, a proposal for a future clinical trial was developed, to provide a foundation for the standardization of outcome measures and trial design in JIA-U. By integrating clinical, imaging, biomarker, and patient-reported outcomes into a unified framework, we aim to accelerate evidence-based therapeutic development and improve long-term care for children affected by anterior uveitis. EXPERT OPINION: A key measure of primary outcome is the anterior chamber cell number, which has intra-observer and inter-observer variation. New techniques that are objective and decrease the variation of the assessment are emerging. Anterior Segmentation Optical Coherence Tomography (OCT) is an innovative imaging technology to assess the number of anterior chamber cells in OCT. The flare meter is an additional assessment, although not yet widely used.