Our primary objective is to study the cellular immune response in CIDP during different stages of disease activity and to explore their role as a biomarker for treatment response and disease activity in patients with CIDP.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) the percentage of the total TCR repertoire representing dominantly expanded
T-cell clones,
(2) the number of circulating lymphocytes subsets and monocytes,
(3) the number of cell divisions during T-cell supression assays.
These paramters will be compared between groups of patients with active disease
and patients without active disease. In individual patients these parameters
will be compared during different states of disease activity.
Secondary outcome
Not applicable.
Background summary
CIDP is an inflammatory neuropathy in which the cellular immune response plays
a major role. CIDP is a heterogeneous disease that responds variably to
treatment and may follow different disease courses. Long-term treatment in CIDP
is particularly challenging as it is accompanied with overtreatment in a
significant number of patients and possibly undertreatment in others.
Biomarkers of disease activity are lacking and urgently needed to guide
maintenance treatment. In this study we will combine different methodological
approaches to study the role of the cellular immune responses and to explore
whether specific features of the cellular immune response can be used as a
biomarker of disease activity.
Study objective
Our primary objective is to study the cellular immune response in CIDP during
different stages of disease activity and to explore their role as a biomarker
for treatment response and disease activity in patients with CIDP.
Study design
Observational multicenter study.
Study burden and risks
The burden to subjects participating in this study is limited to a small number
of study visits which largely overlaps subjects* standard care visit schedule.
Subjects with CIDP remission will perform a single visit. In other participants
blood sampling is performed two or three times, depending on their disease
course.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
- Newly diagnosed untreated patients who fulfill the clinical and electrophysiological EFNS/PNS criteria for CIDP OR
- Patients diagnosed with CIDP according to the clinical and electrophysiological EFNS/PNS criteria for CIDP with maintenance IVIg treatment (> 6 months of treatment) OR
- Patients diagnosed with CIDP according to the clinical and electrophysiological EFNS/PNS criteria for CIDP with a stable clinical condition without treatment in the last 12 months.
- Adult males or females (18 year or more)
Exclusion criteria
Lack of informed consent of the subject.
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 | NL49193.018.14 |