Clinical Research: Phase 1 - Phase 4

Considerations When Operationalizing Trials for Osteoarthritis of the Knee

Treating the chronic pain experienced by patients with osteoarthritis is among the most enduring challenges in analgesic drug development. Operationalizing trials for osteoarthritis of the knee requires careful consideration of study design, strategies for mitigating placebo response, and site selection.

Osteoarthritis, sometimes called degenerative joint disease or degenerative arthritis, occurs when the protective cartilage on the ends of bones wears down over time. The condition most often affects the hands, knees, hips, and spine, though it can damage any joint in the body. The most common form of arthritis, osteoarthritis afflicts an estimated 30 million Americans and 237 million people worldwide.

Osteoarthritis (OA) is the number one cause of disability in the elderly population, with treatment focused mainly on pain management and improvement of function. Currently, there is no cure for OA; however, some treatments attempt to slow disease progression.

Among the biggest challenges of studying osteoarthritis are the heterogeneity of its clinical presentations and the chronic pain associated with the condition. Consequently, operationalizing osteoarthritis trials requires careful consideration and proactive planning. In this white paper, we will provide an overview of osteoarthritis – specifically, osteoarthritis of the knee – and explore the competitive landscape, common study designs, strategies for placebo response mitigation, and important factors for appropriate site selection.

Osteoarthritis overview

According to the Johnston County Osteoarthritis Project – a long- term study from the University of North Carolina, sponsored by the Centers for Disease Control and Prevention and the National Institutes of Health – there is a 46 percent chance that an individual will develop OA of the knee in their lifetime. Women are more likely to develop OA than men, especially after age 50. In fact, the prototypical clinical study patient is a 60-year-old white woman with a body mass index of greater than 30 kg/m2.

To read more, download the complete white paper by submitting the form on this page.