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NCT Number: NCT04881682

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

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

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Key information

Conditions

CIDP Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location status: Recruiting

Location contact

Albert C Ludolph, MD, Prof.

CONTACT

[email protected]

+49-731-177- ext. 1200

Albert C Ludolph, MD, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunoadsorption

Device

see arm/group description

Immunoglobulins

Biological

see arm/group description

Primary outcomes

  1. CIDP Score

    Time frame: 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.

  2. Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

    Time frame: 15 weeks

    Standard clinical score for CIDP, quantifying disability.

  3. Oxford Muscle Strength Score (Medical Research Council, MRC)

    Time frame: 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).

  4. Vibration Score

    Time frame: 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 outcomes

  1. CIDP Score

    Time frame: 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.

  2. Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

    Time frame: 1, 7, and 13 weeks

    Standard clinical score for CIDP, quantifying disability.

  3. Oxford Muscle Strength Score (Medical Research Council, MRC)

    Time frame: 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).

  4. Vibration Score

    Time frame: 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).

  5. Pain

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

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

  6. N20 Latency

    Time frame: 15 weeks

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

  7. P40 Latency

    Time frame: 15 weeks

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

  8. Nerve Conduction Velocity

    Time frame: 15 weeks

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

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

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

    Quality of Life Scale

  10. Immunoglobulin A

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

    Immunoglobulin A serum levels

  11. Immunoglobulin G

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

    Immunoglobulin G serum levels

  12. Immunoglobulin M

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

    Immunoglobulin M serum levels

  13. Interleukin-1

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

    Interleukin-1 serum levels

  14. Interleukin-6

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

    Interleukin-6 serum levels

  15. Anti-contactin-1

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

    Anti-contactin-1 serum levels

  16. Anti-neurofascin155

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

    Anti-neurofascin155 serum levels

  17. Anti-contactin-associated-protein1

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

    Anti-contactin-associated-protein1 serum levels

  18. Anti-neurofascin186

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

    Anti-neurofascin186 serum levels

  19. Anti-neurofascin140

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

    Anti-neurofascin140 serum levels

  20. Neurofilament Light Chain (NfL)

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

    Neurofilament light chain (NfL) serum levels

  21. Therapeutic Response

    Time frame: 15 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Dorst, Prof

CONTACT

[email protected]

+49 731 177 5285

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • Miltenyi Biomedicine GmbH

Registry information

Acronym: IVITOC

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 11, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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