CIDPTAILOR-CIDPNCT07719153
Ultrasound-driven Stratification in CIDP
An observational study of CIDP and Chronic Inflammation, run by Centre Hospitalier Universitaire de Nice.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- CIDP, Chronic Inflammation, Demyelinating Polyneuropathy
- What is being tested?
- Refractory CIDP and Standard-of-care treatment for CIDP
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
- Stable treatment exposure before inclusion according to the final protocol.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-driven Stratification in CIDP: A Prospective Observational Study Integrating Imaging and Circulating Biomarkers
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
- Being tested
- Refractory CIDP, Standard-of-care treatment for CIDP
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refractory CIDPOther
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.
Standard-of-care treatment for CIDPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Refractory CIDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 3
Secondary outcomes (11)
Clinical response status
Clinical response status assessed in Group 1 using predefined response categories
Measured: Month 6 and Month 12
Clinical response status - Hand Grip Strength
Hand Grip Strength assessed in Group 1 using a dynamometer. measure in kg
Measured: Month 6 and Month 12
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
Measured: Month 6 and Month 12
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
Measured: Months 6 and 12
Clinical response status - Timed Up and Go (TUG)
Timed Up and Go (TUG) test performed in Group 1 to evaluate functional mobility - measure in seconds
Measured: Month 6 and Month 12
Clinical response status - Pain Visual Analog Scale (VAS)
Pain intensity assessed in Group 1 with Visual Analog Scale (VAS) from 0 to 10
Measured: Months 6 and 12
Clinical response status - Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity (PGI-S) assessed in Group 1. 1-item questionnaire
Measured: Months 6 and 12
Clinical response status - Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) score assessed in Group 1.6-items
Measured: Months 6 and 12
Association between biomarkers and ultrasound phenotypes
statistical analysis of association of biological elements
Measured: Baseline, Month 3, Month 6, and Month 12
Association between biomarkers and clinical severity
statistical analysis of association of biological and clinical elements
Measured: Baseline, Month 3, Month 6, and Month 12
Association between biomarkers and refractory disease
statistical analysis of association of biological elements
Measured: Baseline, Month 3, Month 6, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719153
- Sponsor's protocol ID
- 26Neuro03
- Acronym
- TAILOR-CIDP
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-driven Stratification in CIDP: A Prospective Observational Study Integrating Imaging and Circulating Biomarkers
- ClinicalTrials.gov ID
- NCT07719153
- Acronym / sponsor ID
- TAILOR-CIDP / 26Neuro03
- Conditions
- CIDP, Chronic Inflammation, Demyelinating Polyneuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve newly diagnosed CIDP | – | Other: Standard-of-care treatment for CIDPParticipants 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. |
| Refractory CIDP | – | Other: Refractory CIDPParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refractory CIDPParticipants 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 |
| Standard-of-care treatment for CIDPParticipants 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 | Treatment-naïve newly diagnosed CIDP |
Primary outcome
Clinical response status to first-line intravenous immunoglobulin (IVIg) for group 1
Time frame: month 3
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.
11 secondary outcomes
Clinical response status
Time frame: Month 6 and Month 12
Clinical response status - Hand Grip Strength
Time frame: Month 6 and Month 12
Clinical response status - Medical Research Council (MRC) Sum Score
Time frame: Month 6 and Month 12
Clinical response status - Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Time frame: Months 6 and 12
Clinical response status - Timed Up and Go (TUG)
Time frame: Month 6 and Month 12
Clinical response status - Pain Visual Analog Scale (VAS)
Time frame: Months 6 and 12
Clinical response status - Patient Global Impression of Severity (PGI-S)
Time frame: Months 6 and 12
Clinical response status - Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Time frame: Months 6 and 12
Association between biomarkers and ultrasound phenotypes
Time frame: Baseline, Month 3, Month 6, and Month 12
Association between biomarkers and clinical severity
Time frame: Baseline, Month 3, Month 6, and Month 12
Association between biomarkers and refractory disease
Time frame: Baseline, Month 3, Month 6, and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP and Chronic Inflammation, run by Centre Hospitalier Universitaire de Nice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Puma (0492035435 ext. +33, puma.ar@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response status to first-line intravenous immunoglobulin (IVIg) for group 1 (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.