Ultrasound-driven Stratification in CIDP
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Refractory CIDP
Other interventionParticipants 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.
Standard-of-care treatment for CIDP
Other interventionParticipants 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 groups
30 Participants
are divided into 2 treatment groupsGroup A: Treatment-naïve newly diagnosed CIDP1 intervention
Group B: Refractory CIDP1 intervention
Trial outcomes
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.
Time frame
month 3Secondary outcomes
1
Clinical response status
Clinical response status assessed in Group 1 using predefined response categories
Time frame
Month 6 and Month 122
Clinical response status - Hand Grip Strength
Hand Grip Strength assessed in Group 1 using a dynamometer. measure in kg
Time frame
Month 6 and Month 123
Clinical response status - Medical Research Council (MRC) Sum Score
Medical Research Council (MRC) Sum Score assessed in Group 1 to evaluate global muscle strength. The total MRC score ranges from 0 to 60
Time frame
Month 6 and Month 124
Clinical response status - Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Inflammatory Rasch-built Overall Disability Scale (I-RODS) score assessed in Group 1 to evaluate to evaluate activity- 24 items, score from 0 to 48
Time frame
Months 6 and 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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