Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Phase 2RecruitingNCT04881682

University of Ulm20 enrolled

Overview

This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

CIDP

Interventions

ImmunoadsorptionDEVICE

see arm/group description

ImmunoglobulinsBIOLOGICAL

see arm/group description

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of possible, probable, or definite CIDP (typical or atypical) according to European Federation of Neurological Societies (EFNS) guidelines * Disease duration of 3 years or less * Age 18 years or above * Previous treatment with methyl-prednisolone and insufficient therapeutic response as judged by the treating physician, or contraindications against methyl-prednisolone, or clinically significant side effects under methyl-prednisolone therapy as judged by the treating physician Exclusion Criteria: * Clinical or laboratory evidence of manifest systemic infection, i.e., C-reactive protein (CRP) above 20 mg/l, or evidence of nitrite-positive urinary tract infection * Intake of angiotensin converting enzyme inhibitor within 1 week before first treatment * immunoglobulin A deficiency * Other contraindications against immunoadsorption or intravenous immunoglobulins

Locations (1)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

CIDP Score

The CIDP Score is a combined score of Inflammatory Cause and Treatment (INCAT) Disability Score, Oxford Muscle Strength Score, and Vibration Score, with each subscore equally weighted.

Time frame: 15 weeks

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

Standard clinical score for CIDP, quantifying disability.

Time frame: 15 weeks

Oxford Muscle Strength Score (Medical Research Council, MRC)

Standard clinical score for evaluation of muscle strength / paresis. Muscle strength is evaluated on a scale between 0/5 (no movement) and 5/5 (full strength) at 8 pre-defined muscles (one proximal and one distal muscle at each extremity).

Time frame: 15 weeks

Vibration Score

Standard clinical score for evaluation of pallesthesia, using a 256 Hz tuning fork. The individual perception threshold for vibration sensations on a scale between 0/8 (no perception) and 8/8 (normal perception) will be determined at 4 predefined spots (processus styloideus radii and malleolus lateralis on each side).

Time frame: 15 weeks

Secondary Outcomes

CIDP Score

The CIDP Score is a combined score of Inflammatory Cause and Treatment (INCAT) Disability Score, Oxford Muscle Strength Score, and Vibration Score, with each subscore equally weighted.

Time frame: 1, 7, and 13 weeks

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

Standard clinical score for CIDP, quantifying disability.

Time frame: 1, 7, and 13 weeks

Central Contacts

Johannes Dorst, Prof

CONTACT

+49 731 177 5285 johannes.dorst@uni-ulm.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Oxford Muscle Strength Score (Medical Research Council, MRC)

Time frame: 16 weeks

Vibration Score

Time frame: 16 weeks

Pain

Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain).

Time frame: 1, 7, 13, and 15 weeks

N20 Latency

N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs).

Time frame: 15 weeks

P40 Latency

P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs).

Time frame: 15 weeks

Nerve Conduction Velocity

Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG).

Time frame: 15 weeks

Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)

Quality of Life Scale

Time frame: 1, 7, 13, and 15 weeks

Immunoglobulin A

Immunoglobulin A serum levels

Time frame: 1, 7, 13, and 15 weeks

Immunoglobulin G

Immunoglobulin G serum levels

Time frame: 1, 7, 13, and 15 weeks

Immunoglobulin M

Immunoglobulin M serum levels

Time frame: 1, 7, 13, and 15 weeks

Interleukin-1

Interleukin-1 serum levels

Time frame: 1, 7, 13, and 15 weeks

Interleukin-6

Interleukin-6 serum levels

Time frame: 1, 7, 13, and 15 weeks

Anti-contactin-1

Anti-contactin-1 serum levels

Time frame: 1, 7, 13, and 15 weeks

Anti-neurofascin155

Anti-neurofascin155 serum levels

Time frame: 1, 7, 13, and 15 weeks

Anti-contactin-associated-protein1

Anti-contactin-associated-protein1 serum levels

Time frame: 1, 7, 13, and 15 weeks

Anti-neurofascin186

Anti-neurofascin186 serum levels

Time frame: 1, 7, 13, and 15 weeks

Anti-neurofascin140

Anti-neurofascin140 serum levels

Time frame: 1, 7, 13, and 15 weeks

Neurofilament Light Chain (NfL)

Neurofilament light chain (NfL) serum levels

Time frame: 1, 7, 13, and 15 weeks

Therapeutic Response

Share of patients with at least 10% improvement in CIDP score compared to baseline.

Time frame: 15 weeks