Clinical trial NCT04881682: Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Official title: Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: CIDP
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Miltenyi Biomedicine GmbH
First posted: 2021-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: CIDP Score
timeFrame: 15 weeks
measure: Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
timeFrame: 15 weeks
measure: Oxford Muscle Strength Score (Medical Research Council, MRC)
timeFrame: 15 weeks
measure: Vibration Score
timeFrame: 15 weeks
Secondary outcomes:
measure: CIDP Score
timeFrame: 1, 7, and 13 weeks
measure: Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
timeFrame: 1, 7, and 13 weeks
measure: Oxford Muscle Strength Score (Medical Research Council, MRC)
timeFrame: 16 weeks
measure: Vibration Score
timeFrame: 16 weeks
measure: Pain
timeFrame: 1, 7, 13, and 15 weeks
measure: N20 Latency
timeFrame: 15 weeks
measure: P40 Latency
timeFrame: 15 weeks
measure: Nerve Conduction Velocity
timeFrame: 15 weeks
measure: Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)
timeFrame: 1, 7, 13, and 15 weeks
measure: Immunoglobulin A
timeFrame: 1, 7, 13, and 15 weeks
measure: Immunoglobulin G
timeFrame: 1, 7, 13, and 15 weeks
measure: Immunoglobulin M
timeFrame: 1, 7, 13, and 15 weeks
measure: Interleukin-1
timeFrame: 1, 7, 13, and 15 weeks
measure: Interleukin-6
timeFrame: 1, 7, 13, and 15 weeks
measure: Anti-contactin-1
timeFrame: 1, 7, 13, and 15 weeks
measure: Anti-neurofascin155
timeFrame: 1, 7, 13, and 15 weeks
measure: Anti-contactin-associated-protein1
timeFrame: 1, 7, 13, and 15 weeks
measure: Anti-neurofascin186
timeFrame: 1, 7, 13, and 15 weeks
measure: Anti-neurofascin140
timeFrame: 1, 7, 13, and 15 weeks
measure: Neurofilament Light Chain (NfL)
timeFrame: 1, 7, 13, and 15 weeks
measure: Therapeutic Response
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurology, University of Ulm
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Johannes Dorst, Prof
role: PRINCIPAL_INVESTIGATOR
References: