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

CIDP Clinical Trial

— IVITOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881682
• Other study ID #: IVITOC 1.1
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2023
• Source: University of Ulm
• Contact: Johannes Dorst, Prof
• Phone: +49 731 177 5285
• Email: johannes.dorst[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CIDP
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Device:
• Immunoadsorption
see arm/group description

Biological:
• Immunoglobulins
see arm/group description

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	Miltenyi Biomedicine GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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