Ultrasound-driven Stratification in CIDP
NCT07719153 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2026-07-22
Summary
Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is a rare autoimmune neuropathy characterized by significant clinical and therapeutic heterogeneity. Despite the availability of effective treatments, the response to intravenous immunoglobulins remains highly variable, and there are currently no validated biomarkers that can predict this response.
At the same time, high-resolution nerve ultrasound now makes it possible to identify different morphological profiles that may reflect distinct pathophysiological mechanisms.
This prospective, observational, single-center study, conducted at the Nice University Hospital, aims to determine whether nerve ultrasound profiles are associated with therapeutic response, clinical severity, and various biomarkers in the blood and cerebrospinal fluid. It includes two predefined cohorts: 20 patients with newly diagnosed PIDC, enrolled before the initiation of immunomodulatory treatment (Group 1), and 10 patients with refractory PIDC and clinically significant disability despite adequate prior treatment (Group 2). The ultimate goal is to develop a stratification strategy that will enable more personalized care for patients with PIDC.
Conditions
- CIDP
- Chronic Inflammation
- Demyelinating Polyneuropathy
Interventions
- OTHER
-
Refractory CIDP
Participants with refractory CIDP will continue or receive treatments according to routine clinical practice. The study does not assign or modify treatment and is limited to observational phenotyping and biomarker analyses.
- OTHER
-
Standard-of-care treatment for CIDP
Participants will receive treatment according to routine clinical practice. In Group 1, first-line treatment will usually consist of intravenous immunoglobulin (IVIg), with subsequent therapeutic decisions made by the treating neurologist according to clinical response and standard care. No investigational intervention is assigned by the study protocol.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Nice
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-09-30
More Related Trials
-
Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT02629796 ·Status: COMPLETED
-
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT01017159 ·Status: COMPLETED ·Phase: PHASE2
-
Biomarkers in Polyradiculoneuropathies
NCT04249752 ·Status: UNKNOWN
-
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02465359 ·Status: COMPLETED ·Phase: NA
-
Transcriptome Analysis of the Peripheral Blood in CIDP
NCT02404298 ·Status: UNKNOWN ·Phase: NA
-
Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT00220740 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Electrical Prognostic Factors of Response to Intravenous Immunoglobulin Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT03967899 ·Status: COMPLETED
-
Study of CIDP Patients During IVIG Treatment
NCT00305266 ·Status: COMPLETED
-
Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg
NCT01349270 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
NCT03779828 ·Status: TERMINATED
-
Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT00001287 ·Status: COMPLETED ·Phase: PHASE2
-
Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing
NCT04356781 ·Status: COMPLETED
-
Immunoglobulin Dosage and Administration Form in CIDP and MMN
NCT02111590 ·Status: COMPLETED
-
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
NCT01655394 ·Status: UNKNOWN
-
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
NCT01545076 ·Status: COMPLETED ·Phase: PHASE3
-
IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements
NCT02414490 ·Status: COMPLETED
-
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
NCT01184846 ·Status: COMPLETED ·Phase: PHASE3
-
InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT04529291 ·Status: WITHDRAWN ·Phase: NA
-
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT06752356 ·Status: RECRUITING ·Phase: PHASE3
-
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
NCT00004772 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02027701 ·Status: COMPLETED ·Phase: PHASE3
-
Predictive Factors of Long Term Outcome in MMN
NCT04015934 ·Status: COMPLETED
-
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT07540221 ·Status: RECRUITING ·Phase: PHASE3
-
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
NCT07264426 ·Status: RECRUITING