Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin (EXPRET)
Primary Purpose
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Muscle Magnetic Resonance Imaging (RMI) evaluation
MRI
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Eligibility Criteria
Inclusion Criteria:
- Suffering from CIDP
- Fulfilling the EFNS/PNS (European Federation of Neurological Societies / Peripheral nerve Society) 2010 revised criteria
- Treated with IVIg or needed to be treated with IVIg
Exclusion Criteria:
- Patients with a known hypersensitivity to the normal human Ig or one of the constituents of the preparation
- Patients with a known IgA deficiency or with anti-IgA circulating antibodies
- Patients with a change in their immunosuppressive or immunomodulatory treatment in the last 6 months
- Patients with a contraindication for MRI explorations
Sites / Locations
- APHM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with CIDP
Arm Description
Outcomes
Primary Outcome Measures
decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore
Secondary Outcome Measures
Full Information
NCT ID
NCT02892890
First Posted
August 29, 2016
Last Updated
July 27, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02892890
Brief Title
Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin
Acronym
EXPRET
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief Summary
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy characterized by an inflammatory multifocal segmental demyelination. Due to the clinical heterogeneity of this condition and the lack of specific marker that can reliably identify all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors predicting the evolution or the prognosis of the disease. Current treatments are the intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the most commonly used. Responses of the patients to the treatments are variable. Thus, it is necessary to identify predictive markers of the therapeutic response of CIDP patients treated by IVIg.
Several potential biomarkers have been proposed recently, but none of them has yet been validated as a predictive criterion for therapeutic response. It is therefore necessary to continue to investigate several biological parameters to identify a reliable biological marker.
In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the axonal loss by a precise count of functional motor units. This method, more sensitive than the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX might be a good tool to better characterize the patients and to follow the course of CIDP. It also might be a new sensitive and reliable marker predictive of the therapeutic response.
Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular diseases. A recent study on CIDP patients reported a significant decrease of the muscle Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical parameters. The use of advances MRI techniques could allow characterizing the structure and composition of muscle and nerve tissues of CIDP patients. It could also be a mean for identifying potential new markers, largely unexplored until now, that might be sensitive to disease course and/or IVIg response.
The objective of this study is to identify predictive markers of the treatment response of CIDP patients receiving IVIg.
This is a prospective observational exploratory study of a cohort of 30 CIDP patients treated with IVIg and followed-up during one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with CIDP
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Muscle Magnetic Resonance Imaging (RMI) evaluation
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suffering from CIDP
Fulfilling the EFNS/PNS (European Federation of Neurological Societies / Peripheral nerve Society) 2010 revised criteria
Treated with IVIg or needed to be treated with IVIg
Exclusion Criteria:
Patients with a known hypersensitivity to the normal human Ig or one of the constituents of the preparation
Patients with a known IgA deficiency or with anti-IgA circulating antibodies
Patients with a change in their immunosuppressive or immunomodulatory treatment in the last 6 months
Patients with a contraindication for MRI explorations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
Direction Recherche Clinique APHM
Official's Role
Study Director
Facility Information:
Facility Name
APHM
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin
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