IgG level variations in predicting optimal treatment of CIDP and MMN
Research type
Research Study
Full title
Do immunoglobulin G level variations in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) patients following initial intravenous immunoglobulin (IVIg) treatment correlate with ultimate dosing requirements?
IRAS ID
193743
Contact name
James Holt
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, days
Research summary
Intravenous immunoglobulin (IVIg) is a recognised treatment for inflammatory disorders including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN). A standard starting dose of 2 g/kg/course, spread over 2-5 days, has been widely used in both research and clinical practice. Due to the chronic nature of CIDP and MMN, most patients with these conditions require repeated doses to avoid relapse, but the frequency of courses and the total dose of IVIg per course required to achieve a steady state varies between patients. Given the risks involved with IVIg, as well as the cost of the product, the lowest possible dose and frequency of administration are considered beneficial. Current strategies to reduce dose and frequency involve assessing clinical response to lower doses, but this is both time consuming and imprecise.
Previous studies have suggested a link between dose frequency in clinically stable CIDP patients on regular IVIg and the change in their IgG levels (∆IgG or dIgG) post-treatment. We aim to study newly diagnosed CIDP and MMN patients as they are started on IVIg and measure IgG levels pre-treatment and then post-treatment at variable intervals. After they have reached a steady-state (defined by three consecutive IVIg courses given at the same frequency and dose) we will do statistical analysis to look at any possible relationships between ∆IgG and course frequency as well as other variables.
Our hypothesis is that ∆IgG in CIDP and MMN patients starting on IVIg is related to frequency of IVIg courses and the dose needed to achieve clinical stability. If this is the case, ∆IgG following intial treatment may be used to predict the expected final dose and allow more ambitious or more cautious dose reductions. This could save time, money and reduce over-treatment, thereby helping both the patient and the health service.REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0767
Date of REC Opinion
29 Jun 2020
REC opinion
Further Information Favourable Opinion