An observational study in CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) and CMT (Charcot Marie Tooth Disease), sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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Among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France — 8 open to participants now, 10 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · France.
Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is the only one that started in 2013, is one of 9 observational ones, and was the 16th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →8 of the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France are open now. Recruiting first, the newest first:
argenx · Sites in France, United States, Argentina and 22 more countries
Ages 18+
argenx · Sites in France, United States, Argentina and 28 more countries
Ages 18+
Dianthus Therapeutics · Sites in France, United States, Argentina and 28 more countries
Ages 18–75
Sanofi · Sites in France, United States, Argentina and 21 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in France, United States, Argentina and 16 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 16
First in 2004; this study’s year is marked. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is close to the median of 49 across 44 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 82 across the 29 interventional studies, 45 across the 9 observational. Of the 25 that completed or were terminated, 12 (48%) have results posted.
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23 of 38 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 1 study filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
5 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT04280718argenxA Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | 2027-04-30 |
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Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main purpose of this study is to assess the clinical feasibility of diffusion tensor imaging (DTI) for the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). For thar purpose, investigator will compare, fractional anisotropy (FA) obtained by diffusion tensor imaging (DTI) MRI 3T on brachial plexus and cervical spinal nerve roots between patients with defined Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), according to the EFNS 2010 criteria, and healthy controls.
The secondary outcomes will be to compare DTI parameters (FA, ADC or Apparent Diffusion Coefficient) between CIDP patients, healthy volunteers, and patients with Charcot Marie Tooth disease type 1a (CMT1a) and MRI morphological parameters (T1, STIR) between these groups. Moreover, investigator will investigate the possible relationship between MRI parameters, clinical indices, and electrophysiological measure.
Investigator will prospectively enroll 15 patients with CIDP followed in the Neurology Department of Clermont Ferrand University Hospital, who satisfy the Joint Task Force of the EFNS and PNS definite CIDP criteria. Two control groups will be studied in parallel, including 15 healthy volunteers on one side, and 15 patients with CMT-1A on the other side (proven by genetic testing). Using a 3-T magnetic resonance imaging scanner, we will obtain DTI scans of brachial plexus of these 3 groups, prepare fractional anisotropy (FA) maps, and compare these values between groups. Investigator will evaluate MRI imaging findings too (coronal STIR, T1-weighted images,and DWIs). MRI studies will be reviewed independently by two neuroradiologists, blinded to clinical informations. In all patients with CIDP, investigator will also performs clinical evaluation and electroneuromyography. Correlation between FA values clinical indices will be examined.
men or women
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 patients with CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy ) who satisfy the definite CIDP criteria of the Joint Task Force of the EFNS and PNS 1 (situations A and B according to the French CIDP work group2), and who agree to undergo cervical MRI.
Diagnostic Test: cervical MRI
15 healthy subjects matched for age and gender to CIDP patients
Diagnostic Test: cervical MRI
15 CMT-1A patients (proven by genetic testing), will be included as Charcot-Marie-Tooth disease type 1A patients (CMT-1A) is one of the main differential diagnoses of CIDP characterized by the diffuse demyelination of peripheral nerves.
Diagnostic Test: cervical MRI
Cervical MRI will be performed in all of the patients and controls on a 3.0-T scanner (Discovery MR750, General Electric (GE) Medical Systems, Milwaukee, WI, USA)
Mean Fractional Anisotropy in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls.
Diffusion Tensor Imaging (DTI) is a modality of Diffusion-Weighted Imaging (DWI). Fractional Anisotropy (FA) and Apparent Diffusion Coefficient (ADC) values, determines the magnitude of directionality of diffusion.
Time frame: At day 1
Apparent Diffusion Coefficient (ADC) values in C5 to C8 nerve roots in CIDP patients compared to CMT-1A patients and healthy controls
Diffusion Tensor Imaging (DTI) is a modality of Diffusion-Weighted Imaging (DWI). Fractional Anisotropy (FA) and Apparent Diffusion Coefficient (ADC) values, determines the magnitude of directionality of diffusion.
Time frame: At day 1
Cervical nerve roots diameter
The diameters of cervical nerve roots (C6-C8) will be measured at the outlet of the intervertebral canal, on coronal STIR sequences, using an ADW 4.5 workstation.
Time frame: at day 1
Clinical data analysis
Disease severity at inclusion (Medical Research Council score (MRC), INCAT sensory sum score (INCAT), Overall Neuropathy Limitation Scale (ONLS)) will be prospectively assessed by the same study investigator. We will also perform nerve conduction studies on all the CIDP patients
Time frame: at day 1
Electrophysiological data analysis : motor conduction
Amplitude of compound muscle action potential (ACMAP),
Time frame: at day 1
Electrophysiological data analysis motor conduction
Motor conduction velocity (MCV)
Time frame: at day 1
Electrophysiological data analysis motor conduction
Motor distal latency (MDL)
Time frame: at day 1
Electrophysiological data analysis motor conduction
F-wave latency (FL)
Time frame: at day 1
Electrophysiological data analysis :motor conduction
terminal latency index (TLI))
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Amplitude of sensitive potential (ASP)
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Sensitive conduction velocity (SCV)
Time frame: at day 1
Electrophysiological data analysis : sensitive conduction
Sensitive distal latency (SDL)
Time frame: at day 1
Ran from Nov 2013 to primary completion in Dec 2015, 25 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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