PRISM 2 - Study of I10E in Patients with CIDP
Research type
Research Study
Full title
International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302
IRAS ID
164908
Contact name
ERIC NEUHART
Contact email
Sponsor organisation
LFB BIOTECHNOLOGIES
Eudract number
2013-005558-31
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
The aim of this study is to assess the efficacy of a medication called I10E administered at a lower dose, called a reduced maintenance dose, to see if I10E can sustain the improvement of disability observed in PRISM I10E-1302 study (the main study of this extension study) for the condition Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Across several countries, approximately 15-30 male and female CIDP patients aged 18 years or more, who have taken part to the main study (PRISM-I10E-1302) will be included in this study. Participation in this study will last in total 48 weeks. During this time, participants will be required to visit the hospital every 3 weeks.
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. Ig medications are slightly different because they are made from donated human blood. The donor pool and the manufacturing process lead to slight differences in properties, so each Ig 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/1235
Date of REC Opinion
8 Jan 2015
REC opinion
Further Information Favourable Opinion