A new clinical research study has been launched that will explore why the current gold standard biological treatment for people with rheumatoid arthritis does not work in around a third of patients. The National Institute for Health Research (NIHR) study in partnership with Janssen will investigate key mechanisms associated with a lack of response to this treatment and its findings should open new routes for developing therapies for these patients.
Run by an NIHR Translational Research Partnership, the study will explore the molecular pathways that determine whether people with rheumatoid arthritis will benefit from treatment with anti-TNF (anti-tumor necrosis factor-alpha) therapies or not.
Anti-TNF therapies are the current gold standard treatment for people with rheumatoid arthritis who do not respond to more widely used anti-rheumatic drugs such as methotrexate. Unfortunately, anti-TNF therapies are not effective in around 30% of these patients. This causes a significant health burden. The reason for this lack of response has been unclear. However, the NIHR's study should provide information that will enable better targeting of anti-TNF therapies and should lead to the development of new and alternative treatments for the up to half a million people in the U.K. affected by rheumatoid arthritis.
The study, which is led by Professor Costantino Pitzalis from Queen Mary University London, is being run by the NIHR Joint and Related Inflammatory Diseases Translational Research Partnership (TRP). It is being funded by Janssen R&D and involves scientists from the organization’s immunology therapeutic area. Set to recruit 50 patients with rheumatoid arthritis from January 2015 over a period of 18 months, this collaborative study will run across seven research centers within the TRP. NOCRI worked closely with Janssen to provide a single point of access to the research expertise across the TRP.
The stratification of patients in this study not only is expected to help define a better approach to experimental medicine in this therapeutic area, but also to support a new way for the pharmaceutical industry to approach early phase drug development. The study is underpinned by a single model agreement between Janssen and twelve of the universities and hospitals that are part of the TRP. This model Industry Collaborative Research Agreement (mICRA) is specifically designed to support multi-center studies like this innovative rheumatology study. NOCRI has supported the establishment of this collaboration, continuing to engage companies, universities and NHS Trusts with new collaborative models.