Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing

NCT04356781 | Completed

• 1 other identifier: RG280-19
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

CIDP and MMN are part of a group of chronic inflammatory conditions that affect the peripheral nervous system. In CIDP, there is chronic inflammation of the peripheral nerves and nerve roots leading to demyelination. The myelin sheath is vital in the rapid propagation of nerve impulses between the central nervous system and the peripheral sensory receptors and muscles. By definition CIDP must progress over 8 or more weeks and can either have a slowly progressive disease course or a relapsing course with periods of improvement. Patients typically present with a non-length dependent neuropathy that affects motor (i.e. weakness of proximal or distal muscles, fatigue, swallowing difficulty, double vision, breathing difficulties etc) and sensory function. MMN is a similar condition to CIDP. It is an autoimmune demyelinating neuropathy that leads to slowly progressive asymmetrical weakness that worsens over years without treatment. IVIg is a recognised treatment for CIDP and 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 modest risks involved with IVIg and its cost, the lowest possible dose and frequency of administration are preferred. Current strategies to reduce dose and frequency involve assessing clinical response to lower doses, but this is both time consuming and imprecise.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Multifocal Motor Neuropathy (MMN)

Keywords

CIDP, IgG, Immunoglobulin, IVIg, transfusion reaction

Outcome Measures

Primary Outcomes (2)

• Link between IgG levels in the blood of patients with CIDP and MMN

  Our primary research objective is to look for a link between ∆IgG levels in the blood of patients with CIDP and MMN following initial IVIg treatment and the ultimate dose required based on clinical response. Other blood tests performed at the time of the IgG level include FBC, U\&E, LFT and ESR (a measure of plasma viscosity) and will allow a look at the effect of IVIg on these parameters. This could provide clarity as there is much variation in practice as to how often routine blood tests such as FBC, U\&E and LFT should be performed in IVIg patients, due to concerns that in some patients there may be biochemical side effects of IVIg treatment. Plasma viscosity may give an indication of risk of thrombotic side effects with IVIg and lead to guidance about, for example, when it is safe to fly after IVIg treatment. Clinical response to treatment will also be recorded

  2 years

• Relationship between IgG and other variables

  Secondary analyses of the data collected will look at relationships between ∆IgG and other variables recorded in the data collection. This would include the demographics of the study population, and the severity and type of their disease.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients with CIDP or MMN starting IVIg under the care of neurologists in The Walton Centre.

You may qualify if:

• Adult patients with CIDP or MMN who are starting Intravenous immunoglobulin in the Walton Centre
• Informed consent

You may not qualify if:

• Previous Intravenous immunoglobulin use in the last year
• Age under 18
• Lack of mental capacity to consent to treatment or to study participation
• Concurrent treatment with steroids or other immunosuppressants

Sponsors & Collaborators

• Walton Centre NHS Foundation Trust: lead
• Instituto Grifols, S.A.: collaborator

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, Merseyside, L9 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Transfusion Reaction

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• James Holt

  Walton Centre NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 22, 2020
• Study Start: September 28, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 17, 2026

Record last verified: 2025-03

Locations

GB (1)