Extrait

Background and study aims Rheumatoid arthritis (RA) is a long-term disease causing pain, swelling and stiffness in the joints. It is a disease of the immune system, known as an autoimmune disease, in which the immune system starts to attack healthy joints. In healthy people, the body produces different types of immune cell. One of these types is the B-cell, which produces antibodies to fight infection. In people with RA, these do not behave properly and produce antibodies which attack a person’s own body even if there is no infection. One of the common treatments for RA is the medication rituximab (RTX). In the body, this medication works to reduce the number of B-cells, stopping them from producing antibodies which will attack the healthy cells. This study is looking at people with RA who are in remission. The aim of this study is to find out whether or not lowering the dose of rituximab in these patients will cause the disease to flare up. Who can participate? Adults diagnosed with rheumatoid arthritis being treated with rituximab with low disease activity/are in remission What does the study involve? Participants are randomly divided into two groups. The first group continues to receive their current does of rituximab (RTX), of 1000mg every 6 months. The second group receives a lower dose of 500mg every 6 months. Participants in each group continue on these doses for two years. They are then be tested to find out whether or not the activity of the disease has increased. What are the possible benefits and risks of participating? There are no immediate benefits of participating in the study. After the results have been analysed (in about 4 years), the time it takes to receive the infusion will be shorter with the reduced dose, causing the treatment to be less inconvenient. Also, the cost of treatment will be less, which could be considered as a benefit. There are no particular risks of participating, however there is a small risk that patients in the lower dose group may experience return of their disease. In that case, rituximab dose may be raised again or it may be necessary to switch to another medication. Where is the study run from? Medical University of Vienna (Austria) When is the study starting and how long is it expected to run for? January 2015 to December 2019 Who is funding the study? Medical University of Vienna (Austria) Who is the main contact? Professor Klaus Machold Kalus.machold@[email protected]

Critère d'inclusion

• Rheumatoid Arthritis

Liens

• ictrp
• isrctn