Extract

Background and study aims Behçet's disease is a rare condition that results in inflammation of the blood vessels and tissues, including inflammation of the eyes. This study involves adult patients who have been diagnosed with Bechet’s disease with eye inflammation that is not responding to treatments such as immunosuppressant drugs, and have eye complications that require surgery. The drug infliximab has been used to treat many conditions related to immune system disorders with promising results, but the drug is still not considered in routine treatment in many countries due to the high cost of the drug and the need for further doses for a long period to prevent the disease from coming back. In countries without medical insurance programs, doctors therefore face a problem treating patients with eye inflammation that is not responding to treatment. The aim of this study is to find out whether infliximab treatment before and after surgery reduces the possible risks of surgery on an inflamed eye, and results in a longer disease-free period (remission) even after stopping the drug. Who can participate? Patients aged 18-60 with Bechet’s disease with severe eye inflammation and vision-threatening complications requiring surgery, and not responding to treatment, including immunosuppressants What does the study involve? All participants are treated with infliximab given directly into a vein, followed by an additional two cycles 2 weeks apart to give a total of three treatment cycles before the intended surgery, to be followed by another three cycles after surgery. The participants are followed-up for any disease activity for up to 6 months. What are the possible benefits and risks of participating? The participants may benefit from being treated with a highly effective and expensive medication that is not covered by their medical insurance in a completely free manner, with the possibility of reducing the daily doses of their current medications, reducing the impact of side effects. The risks are expected to be minimal, as they are related to infliximab side effects, which will be kept to a minimum through careful selection of participants and follow up. Where is the study run from? Cairo University (Egypt) When is the study starting and how long is it expected to run for? February 2014 to January 2016 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Heba El Gendy

Inclusion criteria

• Bechet's disease posterior uveitis

Links

• isrctn