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Inflammatory Neuropathies: the Mechanism of Intravenous Immunoglobulin

Inflammatory Neuropathies: the Mechanism of Intravenous Immunoglobulin - Inflammatory Neuropathies and IVIg

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31804
Enrollment
100
Registered
2007-09-25
Start date
2008-01-14
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune neuropathy/ nerve inflammation

Interventions

Patients with GBS, CIDP and MMN will be treated according to the protocol of the UMC Utrecht. These patients receive a cumulative dose of 2g/kg in 5 consecutive days. Neurological examination will b

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 years Patients with GBS. Patients with CIDP (exacerbation) and MMN who were not treated at least three months prior to inclusion.

Exclusion criteria

Exclusion criteria: Other neuropathies (e.g. diabetic, porphiric, intoxication with medication or metal, vasculitic, Lyme neuroborreliosis, post-radiation, Charcot-Marie-Tooth, hereditary neuropathy with liability to pressure palsies). Patients with an anaphylactic reaction to IVIg in the past.

Design outcomes

Primary

MeasureTime frame
The effect of IVIg on muscle strength and sensory modalities will be measured by comparing neurological examination after treatment (t=5, t=19, t=33) with neurological examination before treatment (t=1). The effects of IVIg treatment on complement component concentration will be measured in every serum sample to monitor the activity of this part of the humoral immune system before, during and after treatment. mRNA will be isolated from blood samples before and after treatment to obtain information about the influence of IVIg on leukocytes, create gene expression profiles and to observe whether there is a difference in expression before and after treatment (concerns cellular immune system). To analyze the sera in more detail, proteomics technology will be used. Surface enhanced laser desorption ionization time of flight (SELDI TOF) analysis allows reproducible measurements in large amounts of sera and is the most powerful method for biomarker identification at this moment.

Secondary

MeasureTime frame
Adverse effects

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)