Clinical Trials

RACE researchers lead or participate in various collaborative clinical trials, including:

(BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis)

Rheumatoid arthritis is a common disease where the immune system attacks the joints, causing joint pain and swelling known as arthritis flares. These flares can substantially reduce quality of life, and are a major burden on patients, carers and their family. Despite this, we know very little about the underlying mechanisms that trigger arthritis flares, partly because their unpredictable nature makes them difficult to scientifically examine. In contrast, some patients with well-controlled RA are able to stop their arthritis drugs without flare, though predicting who can successfully do this remains challenging. In the BIO-FLARE study, we invited patients with RA in remission to stop their arthritis drugs, followed by close monitoring for 6 months with blood, urine, stool and joint biopsy samples. This allows us to identify the changes that occur in the immune system leading up to an arthritis flare, and also the differences between those patients who flare versus those who maintain remission. By doing this, we aim to:

  1. Understand the key immune mechanisms that trigger arthritis flare, shedding light on potential new approaches to treat and prevent arthritis flare in the future.
  2. Identify markers that can predict risk of future flare, supporting further development of new clinical tests to help guide arthritis drug treatment in the clinic.

BIO-FLARE | BIO-FLARE | Newcastle University (

The Centre of Excellence for Trials Collaboration (CETC) is based in the University of Glasgow and helps to support RACE activities: Centre of Excellence for Trials Collaboration. The vision is to position CETC as a world leading centre for pioneering trial methodology and design.

Targeting the Rheumatoid Arthritis synovial fibroblast via cyclin dependent kinase inhibition - an early phase trial (TRAFIC)

  1. Project Leader: Professor John Isaacs
  2. Staff: Dr Arthur Pratt
  3. Sponsors: Newcastle upon Tyne Hospitals NHS Foundation Trust
  4. Partners: Medical Research Council

We plan to test a drug in RA patients that we think will affect the behaviour of fibroblasts. The drug interferes with the machinery necessary for cells to divide. The drug has already been tested in patients with certain types of cancer (in which cells also divide inappropriately). We aim to show that the treatment is safe and that it could provide a useful treatment for RA patients.

The research is divided into two parts. In the first part we will test the safety of different doses of the drug over 4 weeks of treatment, to identify a dose that is safe and appropriate for part two. In the second part we will give this dose to 18 RA patients for 12 weeks. We will check the patients' symptoms and perform scans of their joints at the start and end of the treatment. We will also take small samples of joint tissue (biopsies). These scans and biopsies will help us to decide whether the treatment is working, and how.

Projects - Newcastle Magnetic Resonance Centre - Newcastle University (