Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ulm

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 1 trial group
Group A: Immunoadsorption

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months

Secondary outcomes

1

Inflammatory Neuropathy Cause and Treatment Score (INCAT)

Range 0-10, higher values signify better outome

Time frame
18 months
2

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

Time frame
18 months
3

Vibration Sensitivity

Vibration Sensitivity testing with a Ryder-Seiffel tuning fork

Time frame
18 months
4

Inflammatory Rasch-built Overall Disability Scale (I-RODS)

Range 0-48; higher values signify better outcome

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulm

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Collaborator