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Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin (EXPRET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02892890
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Procedure: Muscle Magnetic Resonance Imaging (RMI) evaluation Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: patients with CIDP Procedure: Muscle Magnetic Resonance Imaging (RMI) evaluation
Device: MRI

Primary Outcome Measures :
  1. decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02892890

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Contact: Shahram Attarian, Professor

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APHM Not yet recruiting
Marseille, France, 13005
Contact: Shahram Attarian, Professor   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: Urielle Desalbres Direction Recherche Clinique APHM

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02892890     History of Changes
Other Study ID Numbers: 2016-24
RCAPHM15_0418 ( Registry Identifier: Assistance Publique Hôpitaux de Marseille )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases