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

Phase 2

Recruiting

• Conditions: CIDP
• Interventions: Device: Immunoadsorption; Biological: Immunoglobulins

• Registration Number: NCT04881682
• Lead Sponsor: University of Ulm

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Study Start: 2023-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunoadsorption	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)
Immunoglobulins	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.

Primary Outcome Measures

Name	Time	Method
CIDP Score	15 weeks	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.
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score	15 weeks	Standard clinical score for CIDP, quantifying disability.
Oxford Muscle Strength Score (Medical Research Council, MRC)	15 weeks	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).
Vibration Score	15 weeks	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurology, University of Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany