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

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

Study Overview

• Status: Recruiting
• Conditions: CIDP
• Intervention / Treatment: Device: Immunoadsorption; Biological: Immunoglobulins

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Johannes Dorst, Prof; Phone Number: +49 731 177 5285; Email: johannes.dorst@uni-ulm.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • Department of Neurology, University of Ulm
      • Contact: Albert C Ludolph, MD, Prof.; Phone Number: 1200 +49-731-177-; Email: albert.ludolph@rku.de
      • Principal Investigator: Albert C Ludolph, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunoadsorption; 3 cycles of immunoadsorption in week 1, 7, and 13 after randomization. One cycle consists of 5 sessions on 5 consecutive days with processing of the 2-fold plasma volume on the first day and the 2.5-fold plasma volume on consecutive days, using regenerative adsorbers (Therasorb, Miltenyi Biotec, Bergisch Gladbach)	Device: Immunoadsorption; see arm/group description
Active Comparator: Immunoglobulins; 5 cycles of intravenous immunoglobulins in week 1, 4, 7, 10, and 13 after randomization. The first cycle consists of 5 intravenous applications of immunoglobulins on 5 consecutive days in a dosage of 0.4 g per kg body weight per day. Subsequent cycles consist of 2 intravenous applications of immunoglobulins on 2 consecutive days in a dosage of 0.5 g per kg body weight per day.	Biological: Immunoglobulins; see arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score	Standard clinical score for CIDP, quantifying disability.	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).	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).	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 7, and 13 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score	Standard clinical score for CIDP, quantifying disability.	1, 7, and 13 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).	16 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).	16 weeks
Pain	Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain).	1, 7, 13, and 15 weeks
N20 Latency	N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs).	15 weeks
P40 Latency	P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs).	15 weeks
Nerve Conduction Velocity	Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG).	15 weeks
Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)	Quality of Life Scale	1, 7, 13, and 15 weeks
Immunoglobulin A	Immunoglobulin A serum levels	1, 7, 13, and 15 weeks
Immunoglobulin G	Immunoglobulin G serum levels	1, 7, 13, and 15 weeks
Immunoglobulin M	Immunoglobulin M serum levels	1, 7, 13, and 15 weeks
Interleukin-1	Interleukin-1 serum levels	1, 7, 13, and 15 weeks
Interleukin-6	Interleukin-6 serum levels	1, 7, 13, and 15 weeks
Anti-contactin-1	Anti-contactin-1 serum levels	1, 7, 13, and 15 weeks
Anti-neurofascin155	Anti-neurofascin155 serum levels	1, 7, 13, and 15 weeks
Anti-contactin-associated-protein1	Anti-contactin-associated-protein1 serum levels	1, 7, 13, and 15 weeks
Anti-neurofascin186	Anti-neurofascin186 serum levels	1, 7, 13, and 15 weeks
Anti-neurofascin140	Anti-neurofascin140 serum levels	1, 7, 13, and 15 weeks
Neurofilament Light Chain (NfL)	Neurofilament light chain (NfL) serum levels	1, 7, 13, and 15 weeks
Therapeutic Response	Share of patients with at least 10% improvement in CIDP score compared to baseline.	15 weeks

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: Miltenyi Biomedicine GmbH
• Investigators: Principal Investigator: Johannes Dorst, Prof, University of Ulm

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Surgical Procedures, Operative; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Immunoglobulins; Plasmapheresis
• Other Study ID Numbers: IVITOC 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
• IPD Sharing Time Frame: 3 months after publication until 5 years after publication
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No