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Recruiting NCT04881682

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

Phase II Interventional CIDP

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunoadsorption, Immunoglobulins.
Who it may be relevant to
Registry conditions: CIDP. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device Immunoadsorption
    see arm/group description
  • Biological Immunoglobulins
    see arm/group description

Primary outcome measures

  • CIDP Score [Time frame: 15 weeks]
  • Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score [Time frame: 15 weeks]
  • Oxford Muscle Strength Score (Medical Research Council, MRC) [Time frame: 15 weeks]
  • Vibration Score [Time frame: 15 weeks]
Secondary outcome measures (12)
  • CIDP Score [Time frame: 1, 7, and 13 weeks]
  • Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score [Time frame: 1, 7, and 13 weeks]
  • Oxford Muscle Strength Score (Medical Research Council, MRC) [Time frame: 16 weeks]
  • Vibration Score [Time frame: 16 weeks]
  • Pain [Time frame: 1, 7, 13, and 15 weeks]
  • N20 Latency [Time frame: 15 weeks]
  • P40 Latency [Time frame: 15 weeks]
  • Nerve Conduction Velocity [Time frame: 15 weeks]
  • Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L) [Time frame: 1, 7, 13, and 15 weeks]
  • Immunoglobulin A [Time frame: 1, 7, 13, and 15 weeks]
  • Immunoglobulin G [Time frame: 1, 7, 13, and 15 weeks]
  • Immunoglobulin M [Time frame: 1, 7, 13, and 15 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Department of Neurology, University of Ulm — Ulm

Identifiers

NCT: NCT04881682 · IVITOC 1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗