Introduction
Osteoarthritis (OA) is a growing problem in the adult population, leading to morbidity, increased health costs and reduced participation in the work force. Information on ongoing trials is essential to better understand future directions of clinical research for OA and optimize the use of research funding. The objective of this study was to conduct a review of active U.S. based clinical trials investigating prevention, symptom resolution, and disease-modifying therapies for osteoarthritis.
Methods
A review of currently active clinical trials for OA using data obtained from the NIH U.S. National Library of Medicine ClinicalTrials.gov database as of August 2020 was conducted. Inclusion criteria were active studies registered in the U.S. that involved the prevention, treatment, or management of OA. Exclusion criteria were trials registered outside of the U.S., studies that evaluated outcome parameters as the primary endpoint that were unrelated to OA, study participants with inflammatory joint disease, non-active clinical trials, or in vitro investigations. Descriptive statistics were recorded and summarized from each trial. Subanalysis was performed for cellular biologics and pharmaceutical drugs.
Results
3859 clinical trials were identified and 310 were included in final analysis. Of the currently active trials, 89% (n=275) targeted symptom resolution in patients with existing OA, 6% (n=19) targeted OA disease-modifying therapeutics, and 5% (n=16) targeted the prevention of OA in high-risk patients. Primary interventions included medical devices (44%, n=137), pharmaceutical drugs (14%, n=42), surgical procedures (14%, n=42), cellular biologics (13%, n=41), and behavioral therapies (13%, n=41). There was a higher number of disease-modifying therapeutics for cellular biologics than pharmaceutical trials (30% vs.14%, respectively). The majority of trials targeted the knee joint (63%) with 38% of all trials evaluating joint arthroplasty. Of those reporting clinical trial phases (n=93), 2% were in early phase I, 18% were in phase I, 41% were in phase II, 22% were in phase III, and 17% were in phase IV. Funding was split between private sector and government (43% and 49%, respectively), with low rate of funding from industry (8%) partners.
Conclusion
There is a broad pipeline of trials evaluating the treatment of OA, with the majority of focus including medical devices, joint replacement surgery, and therapeutic injections. Nearly 90% of currently active U.S. clinical trials target symptomatic resolution for patients with existing OA, with a low number of reported trials targeting OA disease-modifying therapies and prevention of posttraumatic OA development. There was a higher number of disease-modifying therapeutics in the clinical trial pipeline for cellular biologics than pharmaceutical drugs, indicating a promising area of future clinical therapy for OA treatment. Current funding of clinical trials was split between private sector and government, demonstrating an overall lack of industry funding for the treatment and management of OA. The development of OA disease-modifying therapies is essential to reduce the cost and morbidity associated with the increasing prevalence of symptomatic OA in the U.S.