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Trial record 18 of 49 for:    Polyneuropathies | CIDP

sCD163 & CD19 as Candidate Biomarkers in CIDP and MMN

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ClinicalTrials.gov Identifier: NCT02271724
Recruitment Status : Unknown
Verified September 2015 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : October 22, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) are characterized by progressive deterioration in muscle strength, loss of sensibility, diminished or absent reflexes and impaired fine motor control. Often it is caused by demyelination which is suitable for treatment but damage to the axons may also occur especially in case of insufficient treatment.

CIDP and MMN are immune mediated neuropathies in which first choice of treatment is intravenous immunoglobulin (IVIG), although the mechanisms underlying the effect of the IVIG is not yet clarified.

The patients are diagnosed by electrophysiological examination and elevated level of protein in the cerebrospinal fluid. The diagnosis may be difficult to make due to great clinical variation and insensitive examinations methods including lack of biomarkers.

The purpose of this study is to define if patients treated with SCIG and IVIG for CIDP and MMN have higher concentrations of sCD163 and CD19 in their cerebrospinal fluid and serum compared with symptomatic control subjects and is related to disease severity. Furthermore it is to define if patients newly diagnosed with CIDP or MMN have higher levels of sCD163 and CD19, than patients treated regularly with SCIG and IVIG.


Condition or disease Intervention/treatment
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Procedure: Lumbar puncture Procedure: Blood sample

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 85 participants
Official Title: sCD163 & CD19 as Candidate Biomarkers in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - A Study of sCD163 in the Cerebrospinal Fluid
Study Start Date : September 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016


Group/Cohort Intervention/treatment
CIDP/MMN newly diagnosed (drug naive)

Patients, who are suspected to suffer from CIDP or MMN, will undergo a lumbar puncture as a part of the diagnostic procedure. We expect to include 5-10 patients.

Lumbar puncture Blood sample

Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood sample
Blood sample

CIDP/MMN treated

All patients with established CIDP in maintenance treatment with SCIG or IVIG are recruited from local registries at the outpatient clinic at Department of Neurology, Aarhus University Hospital.

We expect that 10-15 patients with CIDP and MMN treated with SCIG or IVIG eligible for inclusion. Furthermore, we expect to include 10 CIDP and MMN patients in maintenance therapy from the outpatient clinics at Department of Neurology, Odense University Hospital and Department of Neurology, Aalborg University Hospital.

Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood sample
Blood sample

Other peripheral neuropathies
Patients who are diagnosed with other causes of peripheral neuropathies than CIDP. We expect to include 20 patients
Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood sample
Blood sample

Syptomatic controls
Controls include patients with unspecified neurological symptoms or diseases who will undergo a lumbar puncture at the Department of Neurology at Aarhus University Hospital as part of their diagnostic work up irrespective of this study plus healthy controls. We expected to include 40-50 symptomatic controls
Procedure: Lumbar puncture
Lumbar puncture for spinal fluid
Other Name: Spinal tap

Procedure: Blood sample
Blood sample




Primary Outcome Measures :
  1. Concentrations of sCD-163 and CD19 in patients with CIDP and MMN. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Concentration of sCD163 and CD19 in newly diagnosed compared with established CIDP and MMN [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples Without DNA
Spinal fluid and blood sample for identification of different factors


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients with CIDP and MMN in maintenance treatment with SCIG or IVIG
  • Patients with newly diagnosed CIDP and MMN (drug-naïve)
  • Patients with other causes of peripheral neuropathies
  • Symptomatic controls
Criteria

Inclusion Criteria:

  • Patients diagnosed with CIDP or MMN or patients suspected to have CIDP or MMN

Controls:

  • Age >18 years

Exclusion Criteria:

  • <18 years
  • Acute infections including neuroinfection
  • Diabetes
  • Other disorders known to have elevated levels of sCD163 and CD19
  • Disorders or treatments that contraindicate a lumbar puncture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271724


Contacts
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Contact: Malalai Musleh, Student +45 27134658 malalaimusleh@hotmail.com
Contact: Henning Andersen, Professor +45 78463281 hennande@rm.dk

Locations
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Denmark
Department of Neurology, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Malalai Musleh, Student    +45 27134658    malalaimusleh@hotmail.com   
Contact: Henning Andersen, Professor    +45 78463281    hennande@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Henning Andersen, Professor Department of Neurology, Aarhus University Hospital

Additional Information:
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02271724     History of Changes
Other Study ID Numbers: CIDP CD163
1-10-72-300-14 ( Other Identifier: The National Committee on Health Research Ethics (Denmark) )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: September 2015
Keywords provided by University of Aarhus:
CIDP
MMN
Spinal fluid
CD163
CD19
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases