28.Nov.2017

OCT to start enrollment in a non-interventional phase IV study

This is an open-label, multi-center, non-interventional study evaluating changes in pain, functional activity and quality of life in patients with knee or hip osteoarthritis.

The study also aims to assess drug utilization and patients’ satisfaction with the study treatment. The duration of the observation period takes to 64 weeks. Male and female patients 45 to 75 years old with hip or knee osteoarthritis stage I to III take part in the study. It is expected to randomize 1500 patients. For this purpose, up to 80 study sites are expected to be involved.

At the moment, no regulatory approved standards for osteoarthritis treatment exist in the Russian Federation. According to recommendations of the Osteoarthritis Research Society International (OARSI) and the European League Against Rheumatism (EULAR), all treatment options for osteoarthritis are classified as non-medical, medical and invasive methods. Such methods provide both symptom modifying and structure-modifying effect, which is based on their positive impact on the disease course.

OCT team is responsible for trial conduct, CRF design and final study report writing. The trial is to be completed by mid-2020.