Extrait

Background and study aims In people with ankylosing spondylitis (AS) a protein called tumour necrosis factor (TNF) is overproduced in the body, causing inflammation and damage to bones, cartilage and tissue. A number of drugs have been developed that block the action of TNF and so can reduce this inflammation. One of these ‘anti-TNF’ drugs is called Etanercept. At the moment the recommended dose for Etanercept is 50 mg per week. This is given as an injection under the skin each week. We are trying to find out if this 50 mg amount is the optimum dose for people with AS. People with rheumatoid arthritis also take Etanercept to ease their joint pain and stiffness. Research has shown that taking lower doses of the drug still produces a good response. At the moment we do not know if this is also true for people with AS. We want to find out if a lower weekly dose of Etanercept still produces a good clinical response for people with AS. If so, this may reduce the side effects this drug can cause. Who can participate? People with AS living in Norfolk who are about to start taking Etanercept are being invited to take part in this research. What does the study involve? Everyone who takes Etanercept is followed up at routine out-patient clinics every 3 months to see how they are getting on. Not everyone who takes Etanercept finds it helps them and three out of ten people see no difference in their symptoms. People taking part in the study will be asked to complete a series of questionnaires about their AS symptoms, quality of life and general health and well-being. No additional tests or procedures are required to take part in the study. After six months, those people who find Etanercept helps their symptoms will be randomly allocated to one of two groups. One group will continue to take Etanercept at the standard 50 mg dose whilst the other group will have their weekly dose reduced by half. Whichever group people are in, they will continue to take Etanercept for a further six months as part of the study. They will attend two more routine out-patient visits (three months apart) where the same questionnaires will be completed. If they are in the lower dose group and there is evidence that their symptoms are getting worse, the dose of Etanercept will be put back up to the standard 50 mg. In total, people will be involved in the study for one year. What are the possible benefits and risks of taking part? Those people in the lower dose group may find they experience fewer side effects than those people who continue on the standard recommended dose. The information we get from this study will help improve the treatment of people with AS in the future. People involved in the study will have slightly longer clinic visits (between ten minutes and half an hour). Some people put in the lower dose group may find the drug stops working or does not work as well as it did before. Where is the study run from? This research is taking place at two NHS hospitals in Norfolk, the Norfolk & Norwich Hospital and the James Paget Hospital. When is the study starting and how log is it expected to run? The study started in October 2010 and finished in August 2013. Who is funding the study? This study is funded by Pfizer Pharmaceuticals (UK). Who is the main contact for the study? Dr Karl Gaffney, Consultant Rheumatologist at the Norfolk & Norwich Hospital

Critère d'inclusion

• Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Liens

• ictrp
• isrctn