Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin (EXPRET)
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|ClinicalTrials.gov Identifier: NCT02892890|
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
|Experimental: patients with CIDP||
Procedure: Muscle Magnetic Resonance Imaging (RMI) evaluation
- decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore [ Time Frame: 15 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT02892890
|Contact: Shahram Attarian, Professorfirstname.lastname@example.org|
|APHM||Not yet recruiting|
|Marseille, France, 13005|
|Contact: Shahram Attarian, Professor email@example.com|
|Study Director:||Urielle Desalbres||Direction Recherche Clinique APHM|