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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

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

Study details
    CIDP

NCT04881682

University of Ulm

26 January 2024

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