PRISM Study: Study of I10E in Patients with CIDP

• Research type

  Research Study

• Full title

  An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy

• IRAS ID

  161184

• Contact name

  ERIC NEUHART

• Contact email

  neuharte@lfb.fr

• Sponsor organisation

  LFB BIOTECHNOLOGIES

• Eudract number

  2013-005557-73

• Research summary

  The aim of this study is to determine if the medicine I10E is a safe and effective treatment for the condition Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Across several countries, 42 men and women CIDP patients aged 18 years or more will be included in this study, with the study requiring 24-26 weeks to complete for each participant.
  CIDP is a rare disease of the peripheral nervous system – nerves outside the brain and spinal column. The disease is quite difficult to diagnose and the root cause is not fully understood, but it’s thought to be linked with the body’s own immune system attacking and damaging the peripheral nerves. This disease affects the nerves and can cause movement and/or sensitivity disorders to upper and lower limbs.
  A common treatment for CIDP is immunoglobulins (Ig) therapy, which are antibodies administered directly into the vein. Antibodies are a key part of the immune system that acts to identify, neutralise and remove substances that could cause harm and their ill effects. It is not known exactly how these Ig therapies work. This study aims to see if this specific Ig medicine called I10E is a safe and effective treatment for improving the disability of patients with CIDP. As all Ig medications are slightly different because they are made from donated human blood, and the donor pool and the manufacturing process lead to slight differences in properties, each must be tested to see if they are safe and capable of treating CIDP.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/1145

• Date of REC Opinion

  21 Oct 2014

• REC opinion

  Further Information Favourable Opinion