Extrait

Background and study aims Patients newly diagnosed with Rheumatoid Arthritis (autoimmune disease that causes inflammation in your joints) are treated conventionally according to National Institute for Health and Clinical Excellence (NICE) guidelines. There is no cure for Rheumatoid arthritis (RA), instead, the goal is to achieve low disease activity and ultimately disease remission. It is not currently possible to predict which drug (or drugs) will produce a favourable response in a particular patient and it is currently difficult to identify patients in clinical remission. This study aims to define predictors of clinical response and define what true remission is in patients with early RA. The plan is to use this information to develop an 'immunological toolkit' to help predict which patients will respond well to particular treatments so that patients can be treated with individualised drug combinations that are most likely to induce and sustain remission. Who can participate? The study will recruit 410 participants over the age of 18 within 4 weeks of diagnosis with Rheumatoid Arthritis. They will not have received disease-modifying antirheumatic drugs (DMARDs) or corticosteroid treatment for the current episode of inflammatory arthritis. In addition all subjects will be positive for Rheumatoid Factor and Anti-citrullinated protein antibody (ACPA). What does the study involve? Patients will receive standard treatment following national guidelines throughout the study period. The study duration will be 18 months. Patients will be assessed at months 0, 3, 6, 9, 12, 15 and 18 using standard validated questionnaires and blood tests as set out in current guidelines. Biological sampling (blood and urine) will be carried out at each assessment for the purpose of developing an 'immunological toolkit'. X-rays will be taken at 0, 12 and 18 months. What are the possible benefits and risks of participating? Although not of direct benefit to participants in the study, it is hoped that the information we get from this study will help improve the treatment of people with rheumatoid arthritis in the future. As this is an observational study there are no additional risks relating to taking medication involved beyond those which you would experience in routine care. However, there is a modest risk of side effects including pain, bruising, light headedness, and, on rare occasions, infection that could arise as a consequence of having blood taken. To minimise this risk, blood will be taken by a clinical professional trained and experienced in taking blood from patients. In all we will need to take seven lots of blood samples from you, in total about 1.5 - 3 egg cups of blood on each occasion, during this study. Where is the study run from? The study is being managed by King's College London. Between 26 and 40 recruitment sites will be set up across England and Scotland. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start Sept/Oct 2012 with the study ending after four years. Who is funding the study? The study is funded as part of a programme grant from the Medical Research Council (MRC). Who is the main contact? Professor Andrew Cope [email protected] Study Co-ordinator [email protected]

Critère d'inclusion

• Rheumatoid Arthritis

Liens

• ictrp
• isrctn