16.Aug.2016

Approval obtained for a phase III clinical trial in patients with rheumatoid arthritis

This is a randomised, double-blind, placebo-controlled, multicenter, parallel group, phase III study aimed to assess the efficacy and safety of the investigational drug in patients with moderate to severe rheumatoid arthritis.

A total of more than 400 men and women aged 18 and older are expected to be randomized. The subjects will be divided into three treatment groups.

Rheumatoid arthritis (RA) is a chronic immune inflammatory disease. In the absence of proper treatment, RA may lead to destruction, deformation and dysfunction of synovial joints, which can be accompanied by dramatic morbidity and expedited mortality. Active moderate-to-severe RA is often treated by standard anti-inflammatory therapy. Despite timely treatment with standard and/or biological disease-modifying drugs, approximately 30-40% of patients with diagnosed RA do not exhibit objective responses to the treatment. Even the majority of those who demonstrate treatment response do not get a remission. Therefore, there is still unmet medical need in new therapeutic approaches for patients experiencing RA.

In this clinical trial OCT was responsible for qualification visits. Our regulatory experts actively supported the Sponsor in the preparation and submission of documents to the Russian regulatory authorities. In addition, OCT provided assistance in the preparation of submissions to the Ministry of Health of the Republic of Belarus, obtaining of clinical trial authorization, export of biological samples and the required paperwork. In the nearest time over 30 investigational sites are expected to be initiated by OCT for this project.

III phase clinical trials are essential part of OCT’s portfolio. Our team successfully completed over 70 projects in this area.