Extrait

Background and study aims Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neuropathy that can lead to considerable disability (walking difficulties and loss of arm dexterity.) Intravenous immunoglobulin (IVIg) is an effective treatment for CIDP. There is however no evidence on how long the treatment should last. This is particularly challenging given the variable and unpredictable course of the disease. In some patients currently treated with IVIg, the disease is actually not active and further treatment is not necessary. Several recent studies have confirmed that there is overtreatment with IVIg. Unfortunately, the only way currently to assess whether treatment is needed is to try and stop treatment. Because of the fear of deterioration in IVIg-dependent patients, attempts to reduce IVIg treatments are not performed frequently. In this study we aim to quantify and reduce overtreatment with IVIg in patients with CIDP. We will introduce a standardised IVIg restabilisation protocol to limit the increase in disability in participants who turn out to be IVIg-dependent. We will explore possible predictors of IVIg dependency to guide long-term IVIg treatment in the future. Who can participate? Adult patients with CIDP currently receiving maintenance IVIg infusions are eligible for this study. What does the study involve? Participants will be randomly allocated to oe of two groups: IVIg withdrawal group or continuation of IVIg treatment group. Participants in IVIg withdrawal group will start with a tapering phase consisting of 3 infusions which will be followed by 100% placebo infusions. Participants in continuation of IVIg treatment group will receive the same IVIg treatment as before the study. All treatments will be provided by home-care nurses. Subjects will be followed for at least 24 weeks after inclusion. What are the possible benefits and risks of participating? Successful IVIg withdrawal will reduce adverse events, the discomfort caused by regular infusions and related health care costs. The main risk is deterioration during the study. Participants will be closely monitored, IVIg treatment will be resumed if the participant’s condition gets worse and the increase in disability will be limited to a very short time period. Where is the study run from? Participants will be recruited from Dutch neuromuscular centers. When is the study starting and how long is it expected to run for? The study will start in April 2014 and is expected to run until October 2016, including a 24-week follow-up period. Who is funding the study? Dutch Governmental grant and by Sanquin Blood Supply. Who is the main contact? Dr Filip Eftimov [email protected]

Critère d'inclusion

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Liens

• ictrp
• isrctn