Clinical Trial: sCD163 & CD19 as Candidate Biomarkers in CIDP and MMN
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: sCD163 & CD19 as Candidate Biomarkers in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - A Study of sCD163 in the Cerebrospinal Fluid
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.
Detailed Summary:
Chronic inflammatory peripheral neuropathies 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. Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) are diagnosed by electrophysiological examination, which shows signs of demyelination and conduction blocks. Moreover, in CIDP an elevated level of protein in the cerebrospinal fluid and in MMN detection of anti-GM1 antibodies in the blood support the diagnosis.
The patients suffer from a disabling diffuse weakness of the muscles. The diagnosis primarily relies on the neurophysiological examination and, however, the diagnosis may be difficult to make due to great clinical variation and insensitive examinations methods including lack of biomarkers.
Treatment of CIDP and MMN 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.
Previous study implies that Fc receptors on natural killer cells is the target for IVIG, because the cytotoxic activity of NK cells was suppressed, partly caused by a dose-dependent decline in the number of circulating NK cells. Furthermore, a dose-dependent blockage of CD16 was present.
Subcutaneous administration of immunoglobulins (SCIG) has been studied as an alternative route to IVIG in CIDP and MMN. The conclusion was that SCIG is feasible, safe and effective. Thus SCIG improved muscle strength, walking performa
Sponsor: University of Aarhus
Current Primary Outcome: Concentrations of sCD-163 and CD19 in patients with CIDP and MMN. [ Time Frame: Day 1 ]
Original Primary Outcome:
- Concentrations of sCD-163 in patients with CIDP and MMN. [ Time Frame: Day 1 ]
- Concentration of sCD163 in newly diagnosed compared with established CIDP and MMN [ Time Frame: day 1 ]
Current Secondary Outcome: Concentration of sCD163 and CD19 in newly diagnosed compared with established CIDP and MMN [ Time Frame: Day 1 ]
Original Secondary Outcome:
Information By: University of Aarhus
Dates:
Date Received: October 9, 2014
Date Started: September 2015
Date Completion: November 2016
Last Updated: May 13, 2016
Last Verified: September 2015
