Extrait

Background and study aims Lower back pain is a common problem, which affects most people at some point in their lives. Many people who experience LBP will recover quickly with no significant impact to their lives, but for some people the pain turns into a long term condition which can affect their ability to work. When a sufferer experiences episodes which last for at least three months, it is known as chronic lower back pain (CLBP). For some patients, their CLBP is caused by inflammation (swelling) in the vertebrae (small bones which make up the spite). Adalimumab is a medication used in patients with inflammatory conditions such as arthritis, as it works by reducing inflammation. The aim of this study is to investigate the effectiveness of treating patients who have CLBP caused by inflammation with adalimumab. Who can participate? Adults with CLBP which is caused by inflammation. What does the study involve? All participants receive a subcutaneous injection (injection under the skin) of 40mg Adalimumab every other week for 12 weeks. During this time, and for two weeks after the end of treatment, participants are askedto keep a record of any pain medication they take, which is reviewed at the start of the study, each time they have an injection and two weeks after the end of treatment. At the start of the study and then after 12 weeks, participants complete a number of questionnaires to assess their pain levels and disability. In addition, participants also have an MRI scan at the start of the study and after 12 weeks to measure the swelling (inflammation) in their spine). What are the possible benefits and risks of participating? Participants may benefit from a reduction in pain and disability. There is a small risk that participants may be more vulnerable to developing an infection while taking the study drug. Where is the study run from? 1. University Hospital of Geneva (Switzerland) 2. HFR- Fribourg Cantonal Hospital (Switzerland) When is the study starting and how long is it expected to run for? July 2010 to January 2015 Who is funding the study? 1. University Hospital of Geneva (Switzerland) 2. AbbVie (USA) Who is the main contact? Dr Stéphane Genevay [email protected]

Critère d'inclusion

• Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes

Liens

• isrctn