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Recruitment target success in rheumatoid arthritis prevention trial

Researchers running a rheumatoid arthritis (RA) prevention trial exceeded their patient recruitment target, despite the challenge of recruiting people who are only at risk of RA, rather than those who already have the disease.

The study is looking at whether a RA therapy can prevent high risk individuals from going on to develop the disabling disease.  The trial, which is supported by the NIHR Joint Translational Research Collaboration which University College London Hospitals BRC is part of, has now recruited more than its target of 206 patients across the UK and the Netherlands.

Professor Andrew Cope, Chief Investigator on the study and Professor of Rheumatology at Kings College and Guys and St Thomas NHS Foundation Trust, said: “This is a really tough study to recruit to because we don’t have access to existing cohorts of patients in the same way that we do for trials of established disease. These at-risk subjects are referred by their GPs to early arthritis clinics cross the UK and the Netherlands. We then have to determine whether they fit the ‘at-risk’ phenotype. It’s tough on these at-risk subjects too, because they are not only having to come to terms with being at risk of a chronic disabling disease, but then have to consider the risks associated with taking a preventative therapy – in this case weekly injections of a biological therapy for 12 months.”

The drug, called abatacept, is already licensed for use in patients with established rheumatoid arthritis. The study is investigating the feasibility, acceptability and effectiveness of a 12 month course of therapy with abatacept. The results from this trial will provide valuable insight into the ‘at-risk’ state and whether this intervention is effective.

The researchers will also investigate immune and inflammatory responses before, during and after therapy with abatacept in order to better understand the immune system at the very earliest detectable stages of the disease.

Professor Cope said: “We chose abatacept because we know it has beneficial effects in patients with established rheumatoid arthritis, it has a good safety profile, and because of its beneficial effects on reducing harmful immune responses.”

Dr Coziana Ciurtin, the study’s Principal Investigator at UCLH, said: “If we find that we can prevent or delay onset of rheumatoid arthritis by taking this approach, this will be really exciting news for patients. Rheumatoid arthritis is a debilitating disease and can be a challenge for patients to manage: the pain and fatigue patients experience affect their quality of life in numerous ways.”

The study has benefited greatly from the support of many patients, patient focus groups and the National Rheumatoid Arthritis Society (NRAS), highlighting the enthusiasm and willingness of the RA community to explore new approaches to finding a cure.

Rheumatoid arthritis is a common chronic inflammatory disease that causes pain, stiffness, swelling and limited motion of joints. It can affect any joint (most commonly the small joints in the hands and feet) and can develop at any age. It is thought that around 400,000 people in the UK are living with the disease.