De lnternational CIDP Outcome Study (ICOS) aims to describe in detail the variation in clinical and electrophysiological subtypes, current practice of treatment, clinical course and outcom in CIDP. The second objective is to define the clinical and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ICOS will result in a combined data- and biobank of well defined patients with
CIDP.
The primary study parameters will include the grip strength measured by using a
Vigorimeter or Jamar dynamometer and the Rasch-MRC sum score. Furthermore we
will use several standardized validated clinical outcome measure scales such
as: Rasch-built Overall Disability Scale(R-ODS), modified INCAT sensory scale,
Pain Intensity Rating scale, Rasch-Fatigue Severity Scale(FSS) and EuroQoL-5D
questionnaire.
Secondary outcome
nvt
Background summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a heterogeneous
disorder with a highly variable clinical presentation. Patients differ greatly
in clinical presentation and clinical course, where some patients develop an
acute form of CIDP with a more rapidly progressive disease course while other
patients have a slow progressive disease course and might need a long course of
treatment. This may indicate the presence of distinct subtypes of CIDP.
Treatment response is also highly variable in CIDP patients, depending on
pathogenesis and disease severity.
The aim of the study is treat CIDP patients with more individual therapy, this
could only be possible if there are prognositc models that accurately predict
the clinical course in individual patients. Ideally such models should be based
on clinical and biological markers that are strongly associated with disease
course. By identifying different subtypes of CIDP may lead to a more
individualised and more effective treatment in CIDP patients.
Further research is requiered to define which determinants can be used to
identify variation in clinical subtypes, clinical course, disease activity,
response to treatment and disease outcome. To address these research questionos
it is requiered to conduct a prospective study with standardized collection of
clinical data and biomaterials from a large group of well defined CIDP patients
during a long follow-up period.
Study objective
De lnternational CIDP Outcome Study (ICOS) aims to describe in detail the
variation in clinical and electrophysiological subtypes, current practice of
treatment, clinical course and outcom in CIDP. The second objective is to
define the clinical and biological determinants and predictors of this
variation in subtypes, disease activity, treatment response and outcome.
Study design
ICOS is a prospective observational international multi-centre study which will
start with a pilot study in 3 Dutch neuromuscular centres. After the pilot
phase, ICOS will expand to more neuromuscular centres in The Netherlands and to
international centres. We aim to include at least 1000 CIDP patients en
variants of CIDP. The study follow-up will be at least 2 years. The ICOS will
result in the largest detailed and standardized databank with data about the
variations in CIDP subtypes, clinical course, disease activity, treatment
regimes, and diagnostics (serum samples, electrophysiology, cerebrospinal fluid
and nerve tissue). Furthermore ICOS will result in a biobank where DNA and
serum samples are collected.
Study burden and risks
Patients with a newly diagnosed CIDP will have more frequent hospital visits
with venapunctures and physical examination, in the context of standard
clinical care and medical work-up. Known CIDP patients are seen less frequent.
The follow-up visits of ICOS are combined with the standard clinical care
visits as much as possible.
Besides the standard clinical care we will also collect clinical data,
questionnaires and blood samples at 4-8 moments. A venapuncture has a very
small risk of formation of hematoma and infection. The majority of CIDP
patients will unidergo an EMG or a lumbar puncture as part of the stand
diagnostic workup. Only in these patients, these data will be collected for the
ICOS. If no lumbar punctore or EMG was performed for various reasons, no lumbar
puncture will be performed in the scope of this study. When a lumbar puncture
is performed, there is a possibility to collect additional 2 ml of CSF for
further reasearch when the patient consents. Collection of these 2 ml extra
results in no additional risks or discomfort for the patient. So for this study
the risks are negligible.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. The ICOS is using the EFNS/PNS criteria (clinical and electrophysiological
criteria) for the diagnosis of CIDP.
Three categories of patients are eligible for the ICOS:
a) Patients fulfilling the clinical criteria and the definite, probable or
possible electrophysiological criteria defined in supplement 1.
b) Patients fulfilling the clinical criteria and at least two supportive
criteria defined in supplement 1.
c) Patients fulfilling the clinical criteria for pure sensory CIDP and at
least two supportive criteria defined supplement 2 (if not fulfilling the
electrophysiological criteria).
2. Being able and willing to conduct a follow-up of at least 2 years.
3. Informed consent.
Exclusion criteria
No exclusion criteria
Design
Recruitment
Medical products/devices used
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 | NL52654.078.15 |