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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02892890
Other study ID # 2016-24
Secondary ID RCAPHM15_0418
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2016
Est. completion date January 9, 2019

Study information

Verified date July 2022
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 9, 2019
Est. primary completion date January 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Polyradiculoneuropathy
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Procedure:
Muscle Magnetic Resonance Imaging (RMI) evaluation

Device:
MRI


Locations

Country Name City State
France APHM Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore 15 months
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Completed NCT02549170 - A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Phase 3
Completed NCT02955355 - Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP Phase 3
Active, not recruiting NCT04658472 - Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2
Withdrawn NCT04529291 - InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy N/A