TRAFIC
Research type
Research Study
Full title
Targeting the Rheumatoid Arthritis Synovial Fibroblast via Cyclin Dependent Kinase Inhibition - an early phase trial (TRAFIC)
IRAS ID
151861
Contact name
John Isaacs
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2014-001339-35
Research summary
Rheumatoid arthritis (RA) is a condition in which joints become inflamed and painful. It is thought to be caused by the patient's immune system mistakenly attacking their joints.
Most drugs currently used to treat RA neutralise the inflammation or the cells of the immune system and their products. Many patients don't respond completely to these treatments, some don't respond at all. We believe there is another type of cell responsible for these patient’s symptoms. Fibroblasts are cells present in healthy joints, where they are important for normal joint function. However, fibroblasts divide inappropriately, becoming more numerous and 'aggressive' in RA. They damage the joint by producing chemicals that eat into cartilage and bone, and also produce inflammatory chemicals.
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.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1075
Date of REC Opinion
15 Sep 2014
REC opinion
Further Information Favourable Opinion