- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892890
Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin (EXPRET)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13005
- APHM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with CIDP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
decrease of at least one point in the ONLS (Overall Neuropathy Limited Scale) sumscore
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Investigators
- Study Director: Urielle Desalbres, Direction Recherche Clinique APHM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-24
- RCAPHM15_0418 (Registry Identifier: Assistance Publique Hôpitaux de Marseille)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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UCB Biopharma SRLCompletedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)United States, Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom
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Nagoya UniversityJapan Agency for Medical Research and Development; Zenyaku Kogyo Co., Ltd.CompletedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Japan
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TakedaRTI Health Solutions; Baxalta Innovations GmbH, now part of ShireCompletedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)United States
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UCB Biopharma S.P.R.L.CompletedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)United States, Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom
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