Extract

Background and study aims The conventional management of rheumatoid arthritis (RA) is based on combinations of simple painkillers (analgesics), non-steroidal anti-inflammatory drugs (NSAIDs) and disease modifying anti-rheumatic drugs (DMARDs), with or without steroids. With such conventional therapy many RA patients have an aggressive course with progressive joint destruction and marked disability developing over 5-10 years. Although it is generally accepted that DMARDs help to slow the course of RA, when DMARDs are used one after another, many patients continue to deteriorate. Together these observations have led to a shift in the management of RA. Firstly, rheumatologists start DMARD therapy as early as possible. Secondly, there is increasing use of combinations of two or more DMARDs given at the same time. The emergence of new therapies for RA has led to renewed optimism in the ultimate ability to control the disease process. There is little doubt that the best management of RA will require combination DMARD therapy. This will need to be started within the first year of disease onset. At present it is not clear what will be the best combination therapy. With an increasing number of new biological agents available to patients, or at various stages of development, the combination of such agents with non-biological DMARDs such as methotrexate, sulphasalazine and gold, should be evaluated. The study will look at whether the addition of a daily injection of Anakinra to normal DMARD (Disease Modifying Anti Rheumatoid Drug) therapy will result in a reduction in the number and severity of joint erosions in patients who have been recently diagnosed with rheumatoid arthritis. The study will also look at other aspects in the management of rheumatoid arthritis, such as control of the level of inflammation and quality of life and collect information on health economics. This will be done using standard validated questionnaires. Who can participate? 159 patients (males and females aged over 18 years with early rheumatoid arthritis (disease duration of less than 12 months at study entry) in participating centres. What does the study involve? Participants receive either only Methotrexate, or Methotrexate with additional daily injections of Anakinra. Each participant will spend 12 months on treatment and then be monitored for a further 12 months. Participants will be assessed at the beginning of the study and 6, 12 and 18 months after this. What are the possible benefits and risks of participating? Patients with early rheumatoid arthritis benefit from taking methotrexate which reduces joint inflammation and pain and improves disability. Anakinra has similar benefits in active rheumatoid arthritis. In established disease the two drugs are more effective in combination that when given singly. Their combined impact in early arthritis is unknown. Like all disease modifying drugs methotrexate can cause minor side effects like rashes and can cause rare side effects like liver damage. We regularly monitor blood tests to minimize the risk of toxicity. Like all biologic treatments Anakinra can increase the risk of infections. It also often causes temporary injection site reactions. Where is the study run from? King's Musculoskeletal Clinical Trials Unit, Kings College London (UK) When is the study starting and how long is it expected to run for? October 2003 to January 2010 Who is funding the study? Amgen Limited (UK) Who is the main contact? Prof. David Scott [email protected]

Inclusion criteria

• Rheumatoid Arthritis

Links

• isrctn
• ictrp