Chronic Inflammatory Demyelinating PolyradiculoneuropathyCIDP echo-nerfNCT05257733
Evaluation of the Diagnostic Contributions of Nerve Ultrasound in Chronic Inflammatory Demyelinating Polyneuropathy Associating Systemic Diseases (CIDP Echo-nerf)
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is an autoimmune disorder of the peripheral nervous system, most commonly affecting the myelin sheath. The pathophysiology of CIDP is not completely understood, but both humoral and cellular immunity appear to be involved in the genesis of this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- What is being tested?
- None, pure observationnal study
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at Nîmes University Hospital between 2012 and 2021 with CIDP
Who may be able to join
- Patients followed at Nîmes University Hospital between 2012 and 2021
- Age > 18 years
- Diagnosis of definite CIDP or possible CIDP according to the new EFNS/PNS 2021 criteria
- Diagnosis of definite CIDP/CIDP possible with systemic diseases and respectively diagnosis of definite CIDP/CIDP possible for the control group confirmed by electroneuromyography, concordant with the clinical examination
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Diagnostic Contributions of Nerve Ultrasound in Chronic Inflammatory Demyelinating Polyneuropathy Associating Systemic Diseases
Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is an autoimmune disorder of the peripheral nervous system, most commonly affecting the myelin sheath. The pathophysiology of CIDP is not completely understood, but both humoral and cellular immunity appear to be involved in the genesis of this disease. Some diseases are particularly associated with CIDP such as diabetes, monoclonal gammopathies and hematological diseases.
CIDP can occur before, after or simultaneously with the onset of systemic diseases. The systemic diseases most often seen in association with polyneuropathies are lupus, Gougerot-Sjögren's syndrome and sarcoidosis.
Ultrasound of peripheral nerves is a useful and accessible tool. In CIDP, this examination can reveal diffuse or segmental nerve hypertrophy. In addition to the size of the nerve, this exploration analyzes the echogenicity and the aspect of the different fascicles within the nerve. S. Goedee et al have shown that nerve ultrasound has very good diagnostic parameters and low interobserver variability in the diagnosis of CIDP. F. Härtig et al suggests that nerve ultrasound can predict the therapeutic response and describes 3 main patterns: hypoechoic enlargement (active inflammation), nerve enlargement with hyperechoic add-on fascicles (axonal degeneration) and almost no enlargement ("cured" CIDP).
Read the detailed description
CIDP may be progressive or relapsing, most frequently clinically symmetric, sensorimotor with proximal and distal involvement developing over at least 8 weeks but variants as distal, multifocal, focal, motor or sensory CIDP have been also described. Cell-mediated and humoral mechanisms act together in an aberrant immune response to cause damage to peripheral nerves but, by molecular mimicry it causes other autoimmune system diseases. This paper focuses on the intersection of CIDP and other autoimmune disease with an emphasis on shared pathology and mutually characteristics.
- Being tested
- None, pure observationnal study
- 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.
None, pure observationnal studyOther
pure observationnal study
| Study group | Role | What they receive |
|---|---|---|
| CIDP associated with systemic diseases | Patients with CIDP associated with systemic diseases Receives: Other: None, pure observationnal study | |
| CIDP without systemic diseases | Patients with CIDP without other systemic diseases Receives: Other: None, pure observationnal study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median nerve cross-sectional area
Comparison of median nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
ulnar nerve at wrist cross-sectional area
Comparison of ulnar nerve at wrist cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
ulnar at mid-arm nerve cross-sectional area
Comparison of ulnar nerve at mid-arm cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
ulnar nerve at elbow cross-sectional area
Comparison of ulnar nerve at elbow cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
radial nerve cross-sectional area
Comparison of radial nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Day of diagnosis of CIDP
superficial radial branch nerve cross-sectional area
Comparison of superficial radial branch nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
vagus nerve cross-sectional area
Comparison of vagus nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
C6 root nerve cross-sectional area
Comparison of C6 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
C5 root nerve cross-sectional area
Comparison of C5 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
sural nerve cross-sectional area
Comparison of sural nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
superficial fibula nerve cross-sectional area
Comparison of superficial fibula nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
tibial nerve at ankle cross-sectional area
Comparison of tibial nerve at ankle cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
popliteal nerve cross-sectional area
Comparison of popliteal nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
fibular nerve at neck cross-sectional area
Comparison of fibular nerve at neck cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
fibular at supra-neck nerve cross-sectional area
Comparison of fibular at supra-neck nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Measured: Base line, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Departure of the project leader
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257733
- Sponsor's protocol ID
- LOCAL/2022/II-01
- Acronym
- CIDP echo-nerf
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt B, Toyka KV, Kiefer R, Full J, Hartung HP, Pollard J. Inflammatory infiltrates in sural nerve biopsies in Guillain-Barre syndrome and chronic inflammatory demyelinating neuropathy. Muscle Nerve. 1996 Apr;19(4):474-87. doi: 10.1002/(SICI)1097-4598(199604)19:43.0.CO;2-9.
PubMed 8622727Sommer C, Koch S, Lammens M, Gabreels-Festen A, Stoll G, Toyka KV. Macrophage clustering as a diagnostic marker in sural nerve biopsies of patients with CIDP. Neurology. 2005 Dec 27;65(12):1924-9. doi: 10.1212/01.wnl.0000188879.19900.b7.
PubMed 16380614Spies JM, Westland KW, Bonner JG, Pollard JD. Intraneural activated T cells cause focal breakdown of the blood-nerve barrier. Brain. 1995 Aug;118 ( Pt 4):857-68. doi: 10.1093/brain/118.4.857.
PubMed 7655884Madia F, Frisullo G, Nociti V, Conte A, Luigetti M, Del Grande A, Patanella AK, Iorio R, Tonali PA, Batocchi AP, Sabatelli M. pSTAT1, pSTAT3, and T-bet as markers of disease activity in chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2009 Jun;14(2):107-17. doi: 10.1111/j.1529-8027.2009.00220.x.
PubMed 19691533Press R, Pashenkov M, Jin JP, Link H. Aberrated levels of cerebrospinal fluid chemokines in Guillain-Barre syndrome and chronic inflammatory demyelinating polyradiculoneuropathy. J Clin Immunol. 2003 Jul;23(4):259-67. doi: 10.1023/a:1024532715775.
PubMed 12959218Mei FJ, Ishizu T, Murai H, Osoegawa M, Minohara M, Zhang KN, Kira J. Th1 shift in CIDP versus Th2 shift in vasculitic neuropathy in CSF. J Neurol Sci. 2005 Jan 15;228(1):75-85. doi: 10.1016/j.jns.2004.10.001. Epub 2004 Nov 12.
PubMed 15607214Kurihara M, Kurata Y, Sugimoto I, Hatanaka Y, Sakurai Y. High PR3-ANCA positivity in a patient with chronic inflammatory demyelinating polyneuropathy. eNeurologicalSci. 2016 Oct 5;6:4-5. doi: 10.1016/j.ensci.2016.10.001. eCollection 2017 Mar.
PubMed 29260006Greenberg SA. P-ANCA vasculitic neuropathy with 12-year latency between onset of neuropathy and systemic symptoms. BMC Neurol. 2002 Oct 31;2(1):10. doi: 10.1186/1471-2377-2-10.
PubMed 12437775Abraham H, Kuzhively J, Rizvi SW. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): An Uncommon Manifestation of Systemic Lupus Erythematosus (SLE). Am J Case Rep. 2017 Sep 12;18:980-983. doi: 10.12659/ajcr.903541.
PubMed 28894082Siddiqui K, Cahalane E, Keogan M, Hardiman O. Chronic ataxic neuropathy with cold agglutinins: atypical phenotype and response to anti-CD20 antibodies. Neurology. 2003 Nov 11;61(9):1307-8. doi: 10.1212/wnl.61.9.1307. No abstract available.
PubMed 14610153Rodriguez Y, Vatti N, Ramirez-Santana C, Chang C, Mancera-Paez O, Gershwin ME, Anaya JM. Chronic inflammatory demyelinating polyneuropathy as an autoimmune disease. J Autoimmun. 2019 Aug;102:8-37. doi: 10.1016/j.jaut.2019.04.021. Epub 2019 May 6.
PubMed 31072742Wolbert J, Cheng MI, Meyer zu Horste G, Su MA. Deciphering immune mechanisms in chronic inflammatory demyelinating polyneuropathies. JCI Insight. 2020 Feb 13;5(3):e132411. doi: 10.1172/jci.insight.132411.
PubMed 32051341Seeliger T, Prenzler NK, Gingele S, Seeliger B, Korner S, Thiele T, Bonig L, Suhs KW, Witte T, Stangel M, Skripuletz T. Neuro-Sjogren: Peripheral Neuropathy With Limb Weakness in Sjogren's Syndrome. Front Immunol. 2019 Jul 11;10:1600. doi: 10.3389/fimmu.2019.01600. eCollection 2019.
PubMed 31354737
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Contributions of Nerve Ultrasound in Chronic Inflammatory Demyelinating Polyneuropathy Associating Systemic Diseases
- ClinicalTrials.gov ID
- NCT05257733
- Acronym / sponsor ID
- CIDP echo-nerf / LOCAL/2022/II-01
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Departure of the project leader
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Feb 2022 (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 an autoimmune disorder of the peripheral nervous system, most commonly affecting the myelin sheath. The pathophysiology of CIDP is not completely understood, but both humoral and cellular immunity appear to be involved in the genesis of this disease. Some diseases are particularly associated with CIDP such as diabetes, monoclonal gammopathies and hematological diseases.
CIDP can occur before, after or simultaneously with the onset of systemic diseases. The systemic diseases most often seen in association with polyneuropathies are lupus, Gougerot-Sjögren's syndrome and sarcoidosis.
Ultrasound of peripheral nerves is a useful and accessible tool. In CIDP, this examination can reveal diffuse or segmental nerve hypertrophy. In addition to the size of the nerve, this exploration analyzes the echogenicity and the aspect of the different fascicles within the nerve. S. Goedee et al have shown that nerve ultrasound has very good diagnostic parameters and low interobserver variability in the diagnosis of CIDP. F. Härtig et al suggests that nerve ultrasound can predict the therapeutic response and describes 3 main patterns: hypoechoic enlargement (active inflammation), nerve enlargement with hyperechoic add-on fascicles (axonal degeneration) and almost no enlargement ("cured" CIDP).
Detailed description
CIDP may be progressive or relapsing, most frequently clinically symmetric, sensorimotor with proximal and distal involvement developing over at least 8 weeks but variants as distal, multifocal, focal, motor or sensory CIDP have been also described. Cell-mediated and humoral mechanisms act together in an aberrant immune response to cause damage to peripheral nerves but, by molecular mimicry it causes other autoimmune system diseases. This paper focuses on the intersection of CIDP and other autoimmune disease with an emphasis on shared pathology and mutually characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIDP associated with systemic diseases | – | Other: None, pure observationnal studyPatients with CIDP associated with systemic diseases |
| CIDP without systemic diseases | – | Other: None, pure observationnal studyPatients with CIDP without other systemic diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at Nîmes University Hospital between 2012 and 2021 with CIDP
Key inclusion criteria (4 listed)
- Patients followed at Nîmes University Hospital between 2012 and 2021
- Age > 18 years
- Diagnosis of definite CIDP or possible CIDP according to the new EFNS/PNS 2021 criteria
- Diagnosis of definite CIDP/CIDP possible with systemic diseases and respectively diagnosis of definite CIDP/CIDP possible for the control group confirmed by electroneuromyography, concordant with the clinical examination
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| None, pure observationnal studypure observationnal study | Other | CIDP associated with systemic diseases, CIDP without systemic diseases |
Primary outcome
Median nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of median nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
ulnar nerve at wrist cross-sectional area
Time frame: Base line, Day 0
Comparison of ulnar nerve at wrist cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
ulnar at mid-arm nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of ulnar nerve at mid-arm cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
ulnar nerve at elbow cross-sectional area
Time frame: Base line, Day 0
Comparison of ulnar nerve at elbow cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
radial nerve cross-sectional area
Time frame: Day of diagnosis of CIDP
Comparison of radial nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
superficial radial branch nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of superficial radial branch nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
vagus nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of vagus nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
C6 root nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of C6 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
C5 root nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of C5 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
sural nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of sural nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
superficial fibula nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of superficial fibula nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
tibial nerve at ankle cross-sectional area
Time frame: Base line, Day 0
Comparison of tibial nerve at ankle cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
popliteal nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of popliteal nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
fibular nerve at neck cross-sectional area
Time frame: Base line, Day 0
Comparison of fibular nerve at neck cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
fibular at supra-neck nerve cross-sectional area
Time frame: Base line, Day 0
Comparison of fibular at supra-neck nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Results publication: PubMed 8622727Schmidt B, Toyka KV, Kiefer R, Full J, Hartung HP, Pollard J. Inflammatory infiltrates in sural nerve biopsies in Guillain-Barre syndrome and chronic inflammatory demyelinating neuropathy. Muscle Nerve. 1996 Apr;19(4):474-87. doi: 10.1002/(SICI)1097-4598(199604)19:43.0.CO;2-9.
- Results publication: PubMed 16380614Sommer C, Koch S, Lammens M, Gabreels-Festen A, Stoll G, Toyka KV. Macrophage clustering as a diagnostic marker in sural nerve biopsies of patients with CIDP. Neurology. 2005 Dec 27;65(12):1924-9. doi: 10.1212/01.wnl.0000188879.19900.b7.
- Results publication: PubMed 7655884Spies JM, Westland KW, Bonner JG, Pollard JD. Intraneural activated T cells cause focal breakdown of the blood-nerve barrier. Brain. 1995 Aug;118 ( Pt 4):857-68. doi: 10.1093/brain/118.4.857.
- Results publication: PubMed 19691533Madia F, Frisullo G, Nociti V, Conte A, Luigetti M, Del Grande A, Patanella AK, Iorio R, Tonali PA, Batocchi AP, Sabatelli M. pSTAT1, pSTAT3, and T-bet as markers of disease activity in chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2009 Jun;14(2):107-17. doi: 10.1111/j.1529-8027.2009.00220.x.
- Results publication: PubMed 12959218Press R, Pashenkov M, Jin JP, Link H. Aberrated levels of cerebrospinal fluid chemokines in Guillain-Barre syndrome and chronic inflammatory demyelinating polyradiculoneuropathy. J Clin Immunol. 2003 Jul;23(4):259-67. doi: 10.1023/a:1024532715775.
- Results publication: PubMed 15607214Mei FJ, Ishizu T, Murai H, Osoegawa M, Minohara M, Zhang KN, Kira J. Th1 shift in CIDP versus Th2 shift in vasculitic neuropathy in CSF. J Neurol Sci. 2005 Jan 15;228(1):75-85. doi: 10.1016/j.jns.2004.10.001. Epub 2004 Nov 12.
- Results publication: PubMed 29260006Kurihara M, Kurata Y, Sugimoto I, Hatanaka Y, Sakurai Y. High PR3-ANCA positivity in a patient with chronic inflammatory demyelinating polyneuropathy. eNeurologicalSci. 2016 Oct 5;6:4-5. doi: 10.1016/j.ensci.2016.10.001. eCollection 2017 Mar.
- Results publication: PubMed 12437775Greenberg SA. P-ANCA vasculitic neuropathy with 12-year latency between onset of neuropathy and systemic symptoms. BMC Neurol. 2002 Oct 31;2(1):10. doi: 10.1186/1471-2377-2-10.
- Results publication: PubMed 28894082Abraham H, Kuzhively J, Rizvi SW. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): An Uncommon Manifestation of Systemic Lupus Erythematosus (SLE). Am J Case Rep. 2017 Sep 12;18:980-983. doi: 10.12659/ajcr.903541.
- Results publication: PubMed 14610153Siddiqui K, Cahalane E, Keogan M, Hardiman O. Chronic ataxic neuropathy with cold agglutinins: atypical phenotype and response to anti-CD20 antibodies. Neurology. 2003 Nov 11;61(9):1307-8. doi: 10.1212/wnl.61.9.1307. No abstract available.
- Results publication: PubMed 31072742Rodriguez Y, Vatti N, Ramirez-Santana C, Chang C, Mancera-Paez O, Gershwin ME, Anaya JM. Chronic inflammatory demyelinating polyneuropathy as an autoimmune disease. J Autoimmun. 2019 Aug;102:8-37. doi: 10.1016/j.jaut.2019.04.021. Epub 2019 May 6.
- Results publication: PubMed 32051341Wolbert J, Cheng MI, Meyer zu Horste G, Su MA. Deciphering immune mechanisms in chronic inflammatory demyelinating polyneuropathies. JCI Insight. 2020 Feb 13;5(3):e132411. doi: 10.1172/jci.insight.132411.
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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. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 0 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: withdrawn, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median nerve cross-sectional area (time frame: Base line, Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257733, which also lists 13 linked publications.
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 5 Apr 2024.