About this trial
This study is designed as an explorative study aiming at exploring safety and efficacy of immunoadsorption (IA) in patients with Chronic Inflammatory Demyelinating Poly-neuropathy (CIDP) compared to intravenous immunoglobulins (IVIg) and methyl-prednisolone (MP). For this purpose, approximately 140 patients with CIDP will be included within the framework of the German multicenter network "Kompetenznetz Peripherer Nerv" (KKPNS).
The study will be purely observational. IA will be performed as an escalation therapy, i.e., in patients who did not respond to IVIg and/or MP treatment. Patients will be included in the study during ongoing IVIg or MP treatment and switched to IA during the 18-month observation period in case of an insufficient response. IA will be performed according to the therapeutic scheme of each participating center. A non-mandatory recommendation for number of sessions, treatment volumes, and frequency will be given (see below). Six-month follow-up visits including collection of standardized clini-cal data will be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of CIDP based on the EAN/PNS Guidelines on Diagnosis and Treatment of CIDP13
age ≥ 18 years
Willing and capable of giving written informed consent
Currently receiving IVIg or MP treatment OR starting IVIg or MP treatment at baseline
Disqualifiers
none
Trial population
CIDP patients currently under treatment with immunoglobulins or steroids will be included in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
The CIDP score is a combined clinical score comprising the Inflammatory Neuropathy Cause and Treatment Score (INCAT), the Medical Research Council (MRC) and Vibrations Sensitivity Testing with a 256 Hz Ryder-Seiffel tuning fork. Range 0-480, higher values signify better outcome.
Secondary outcomes
Inflammatory Neuropathy Cause and Treatment Score (INCAT)
Range 0-10, higher values signify better outome
Medical Research Council (MRC)
Range 0-160; higher values signify better outcome. Musle power between 0/5 and 5/5 will be measured at 8 predifined muscle groups (agonist and antagonist, left and right, respectively) on upper and lower extrimities
Vibration Sensitivity
Vibration Sensitivity testing with a Ryder-Seiffel tuning fork
Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Range 0-48; higher values signify better outcome
Sponsors and contacts
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University of Ulm
Lead sponsor
Fresenius Medical Care Deutschland GmbH
Collaborator