Issues in structure-modifying osteoarthritis drug development: new insights regarding radiographic clinical trial methods

Background

Over the past several decades, the osteoarthritis (OA) field has relied on radiographs in clinical trials, in order to assess longitudinal structural changes in weight-bearing joints such as the knee. Because alternative imaging modalities such as magnetic resonance imaging are beginning to mature, it is timely to compare and contrast the utility of these imaging methods for the purpose of conducting future structure-modifying OA drug clinical trials

Objective

Insights from a large, multicenter knee OA study will be shared in the context of considering the next generation of longitudinal imaging methods to study OA.

Methods

Patients in the study all had radiographic and symptomatic knee OA. A total of 2400 patients were randomized to the study, with an 85% study completion rate. The radiographic data for the study were collected at baseline, month 12 and month 24, using a highly standardized radiographic method directed at the medial compartment of the signal knee. Fluoroscopic confirmation of proper knee position was achieved at each study visit.

Results

A 2-year, 2400-patient study of knee OA has been completed and is being analyzed. Insights will be shared at the GARN Conference.