-To evaluate the effects of IVIg on the humoral and cellular immune system.-To identify biomarkers which are associated with the effect (on muscle strength and sensory modalities) of IVIg. To investigate the value of these biomarkers in other…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Adverse effects
Background summary
Intravenous immunoglobulins (IVIg) are known to be efficacious in many
inflammatory and autoimmune diseases. The activity of IVIg is complex and
incompletely understood; it involves effects on the cellular and humoral immune
system. Inflammatory neuropathies include Guillain-Barré syndrome (GBS),
chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor
neuropathy (MMN). These three polyneuropathies are presumed to be caused by
immunemediated demyelination. The treatment of choice for patients with GBS and
MMN is administration of IVIg. A significant percentage CIDP patient responds
favorably to IVIg. Muscle strength increases and sensory loss decreases. MMN
and CIDP patients are often treated with maintenance treatment. Our aim is to
evaluate the effects of IVIg on the humoral and cellular immune system and to
identify biomarkers to increase the understanding about the mechanism and
strive for improvement of treatment in the future. Furthermore we want to
investigate the value of these biomarkers in other immunemediated neuropathies.
Study objective
-To evaluate the effects of IVIg on the humoral and cellular immune system.
-To identify biomarkers which are associated with the effect (on muscle
strength and sensory modalities) of IVIg. To investigate the value of these
biomarkers in other immunemediated neuropathies.
Study design
Monocenter prospective cohort study for a period of three years
Intervention
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 be performed before and after
treatment (t=1, t=5, t=19, t=33). At neurological examination the sensory
modalities touch, pain, vibration and position sense will be tested and muscle
strength will be tested by manual muscle testing bilaterally in arm and leg (in
total 20 muscles/ muscle groups, MRC grading) and by hand-held dynamometry.
Blood samples will be taken every day during treatment plus two and four weeks
after treatment (t=19, t=33).
Study burden and risks
The burden includes five venous punctures in five days followed by two venous
punctures two and four weeks after treatment. There is a risk in developing a
hematoma at the puncture site.
Oudegracht 362 bisA
3511PN Utrecht
NL
Oudegracht 362 bisA
3511PN Utrecht
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17346.041.07 |