Ultrasound-driven Stratification in CIDP

NCT07719153 | Not Yet Recruiting

• 1 other identifier: 26Neuro03
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical response status to first-line intravenous immunoglobulin (IVIg) for group 1

  Clinical response status at Month 3 after initiation of first-line IVIg in treatment-naïve patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Response categories will be predefined and may include remission, responder, partial responder, and non-responder, based primarily on adjusted INCAT and Hand Grip Strength.

  month 3

Secondary Outcomes (11)

• Clinical response status

  Month 6 and Month 12

• Clinical response status - Hand Grip Strength

  Month 6 and Month 12

• Clinical response status - Medical Research Council (MRC) Sum Score

  Month 6 and Month 12

• Clinical response status - Inflammatory Rasch-built Overall Disability Scale (I-RODS)

  Months 6 and 12

• Clinical response status - Timed Up and Go (TUG)

  Month 6 and Month 12

Study Arms (2)

Treatment-naïve newly diagnosed 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.

Other: Standard-of-care treatment for CIDP

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: Refractory CIDP

Interventions

Refractory CIDP OTHER

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.

Refractory CIDP

Standard-of-care treatment for CIDP OTHER

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.

Treatment-naïve newly diagnosed CIDP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 30 consecutive adult patients with CIDP followed at the Peripheral Nervous System and Muscle Department of CHU Nice. The cohort will include 20 treatment-naïve patients with newly diagnosed CIDP enrolled before initiation of immunomodulatory therapy and 10 patients with established refractory CIDP and persistent clinically relevant disability despite adequate prior treatment. All participants will be assessed within the standard diagnostic and therapeutic care pathway for CIDP.

You may qualify if:

• Male or female aged 18 years or older.
• Diagnosis of CIDP according to the 2021 EAN/PNS criteria; eligible phenotypes include typical CIDP, asymmetric CIDP (MADSAM/Lewis-Sumner syndrome), and pure motor CIDP. Pure sensory CIDP is excluded.
• Ability to undergo protocol assessments, including clinical evaluation, electrophysiological studies, nerve ultrasound, and blood sampling.
• Ability to provide written informed consent.
• Affiliation with a health insurance system or equivalent.
• Group 1-specific criteria:
• Newly diagnosed CIDP.
• No previous immunomodulatory treatment for CIDP before baseline study assessment.
• Planned initiation of IVIg according to standard clinical practice.
• Group 2-specific criteria:
• Established CIDP with persistent clinically relevant disability.
• Documented inadequate, partial, transient, or absent response despite adequate prior therapy, according to the final refractory disease definition.

You may not qualify if:

• Pure sensory CIDP.
• Alternative cause of neuropathy, including hereditary, metabolic, toxic, or other acquired neuropathies judged to better explain the clinical picture.
• Motor neuron disease, myopathy, neuromuscular junction disorder, or another neurological or neuromuscular condition interfering with clinical, electrophysiological, or ultrasound interpretation.
• CIDP mimic or alternative diagnosis.
• Active infection likely to influence study assessments.
• Active malignancy or other major systemic condition likely to confound biomarker interpretation.
• Concomitant autoimmune or inflammatory disease likely to materially influence cytokine or complement measurements.
• Severe psychiatric or cognitive disorder interfering with participation.
• Participation in another interventional trial when incompatible with the present protocol.
• Inability or unwillingness to comply with study procedures.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Angela Puma

CONTACT

0492035435; puma.ar@chu-nice.fr

Abderhmane Slioui

CONTACT

0492038953; slioui.a@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07