Extrait

Background and study aims Rheumatoid arthritis is a major health problem that affects one adult in a hundred. Its NHS costs exceed £500 million yearly. The main problem in rheumatoid arthritis is swollen (inflamed) joints. If persistent these cause disability and reduce quality of life. It is accepted that patients with active early rheumatoid arthritis need intensive care. This type of care results in reduction in one third of patients. Such reductions minimise disability and maximise quality of life. However, two thirds of active patients fail to achieve this reduction. Their ongoing grumbling arthritis - neither active nor in remission - means most of them are likely to become very disabled in the fullness of time with current treatment approaches. This study focuses on these patients. It is designed to find out whether intensive care results in more reduction of disease in patients with intermediate disease activity. It will also see whether intensive management reduces disability, enhances quality of life and is acceptable to patients. Who can participate? The study will involve men and women aged over 18 years who have a diagnosis of Rheumatoid Arthritis. What does the study involve? Participants will be randomly chosen to receive intensive management or standard care. Patients receiving intensive management will have monthly sessions with a specialist nurse/health practitioner, drug treatment will be optimised and treatment support regarding pain management, exercise and adherence will be given. The other group will receive standard care. All participants will be in the trial for 12 months. Patients will be assessed initially and at six and 12 months through self-completed questionnaires and clinical evaluation. What are the possible benefits and risks of participating? There may not be any direct benefit to participants taking part in the study; however, their arthritis will be monitored very closely by the research team, and it is hoped that this research will help improve the treatment and management of rheumatoid arthritis for all patients in the future. The risks involved in taking part in the study are small. Patients receiving intensive management are likely to receive more drug therapy. While it is possible that this will result in more side effects, there is little evidence that this will occur. This is because close monitoring and adjustment of treatment is more likely to limit the risk of side effects. Where is the study run from? The study will be recruiting through rheumatology departments across England. The study will be run from King's College London (UK). When is the study starting and how long is it expected to run for? Recruitment will begin around April 2014. Each participant is expected to be enrolled in the trial for a period of 12 months. The study is due to end in July 2017. Who is funding the study? The study is funded by a National Institute for Health Research (NIHR), UK. Who is the main contact? Professor David L Scott [email protected]

Critère d'inclusion

• Rheumatoid Arthritis

Liens

• ictrp
• isrctn