Extrait

Background and study aims This is a research study being carried out at six hospitals in the UK. It will look back over 3 years at how well patients with multiple sclerosis (MS) respond to medicines known as disease modifying therapies (DMTs), which are used to treat MS. We are also looking at the effect a relapse has on the everyday life of a person with MS. DMTs have all been tested in clinical trials and approved for treating patients, but in this study we want to get more information about the experience of patients using them. This study is designed to increase understanding of how well DMTs work as initial treatments for Relapsing Remitting MS (RRMS), in patients’ real-world setting rather than in formal clinical trials. We understand the progression and accumulation of disability in the later stages of MS quite well, but the physical, psychological and financial impact of relapses in early disease is less clear and potentially underestimated. Differing perceptions between physicians and patients on the nature and severity of a relapse may contribute to this. Who can participate? Patients with a diagnosis of RRMS, and who started a DMT for the first time in 2008, will be eligible to participate. What does the study involve? Patients will be identified at 6 UK centres and will be invited to participate by post. They will be sent an information sheet, and details of a person to contact if they require further information. Once the consent has been returned (by post), the participant will be enrolled in the study and will receive another package by post. Included in this pack are a retrospective questionnaire to provide information on the participant’s experience of their last relapse, and three short questionnaires to inform us of their current health status. Once this is returned, the participant will have completed their role in study. We will also look at the medical records of those who allow us to do so. We will look at the number of relapses that occur in the 3 years after the first prescription of DMTs, any changes in medication, and the number of clinic visits needed during this time. What are the possible benefits and risks of participating? There are no direct risks or benefits to the participant in this study as there will be no change in patient care. The benefit is adding to the literature in this area to inform clinical and policy decisions about patient care. Where is the study run from? This study is coordinated independently by pH Associates. The six centres taking part will be: The Royal Victoria Infirmary - Newcastle, Queens Hospital - Romford, Charing Cross Hospital - London, Leicester General Infirmary - Leicester, Norfolk and Norwich University Hospital – Norwich, and Morristen Hospital - Swansea. When is study starting and how long is it expected to run for? May 2012 to December 2012. Who is funding the study? Novartis Pharmaceuticals UK Ltd (UK) Who is the main contact? Heather Davies [email protected] Lucinda Davies (pH Associates) [email protected]

Critère d'inclusion

• Multiple sclerosis

Liens

• isrctn
• ictrp