Monday 28 January 2019

Recruitment target success in rheumatoid arthritis prevention trial

The research team behind a clinical trial to investigate a preventative therapy for rheumatoid arthritis are greatly encouraged after exceeding their patient recruitment target.

The study, supported by the NIHR Joint Translational Research Collaboration, had a target of recruiting 206 patients from hospitals across the UK and Netherlands, and this month they announced that they have successfully completed recruitment.

The randomised, double blind, placebo-controlled clinical trial aims to determine whether rheumatoid arthritis (RA) can be prevented if therapy is given to individuals at high risk of developing the disease. A patient is defined as high risk if there is a presence of autoantibodies in the blood, together with joint symptoms (pain but not joint swelling).

Professor John Isaacs leads the Musculsokeletal Research theme with the NIHR Newcastle Biomedical Research Centre (BRC) and was involved in this collaborative study. Professor Isaacs commented: “We were delighted to be part of this work with NIHR colleagues. We have a robust patient network here in Newcastle and were able to contribute significantly to the recruitment target, which will lead us to important discoveries into the way that we diagnose and treat rheumatic conditions at an early stage. ”

Also involved from the NIHR Newcastle BRC was Dr Arthur Pratt, who led Newcastle successful recruitment activity.

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 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 Rheumatoid Arthritis community to explore new approaches to finding a cure. 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.”

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.

Support for future studies in rheumatoid arthritis

An important outcome of this study for ongoing trials into rheumatic conditions in Newcastle, was the ability to demonstrate that it is feasible to recruit at-risk and early rheumatoid arthritis patients to such trials. This was an important principle to establish given the relevance to other trials that are being undertaken by Professor Isaacs, such as the major pan-European study, RT-CURE, which aims to prevent patients who may be at risk of rheumatoid arthritis from progressing to later stages of the disease.