About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: ImmunoadsorptionExperimental treatment 1 intervention

Group B: ImmunoglobulinsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

CIDP Score

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.

Time frame

15 weeks

2

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

Standard clinical score for CIDP, quantifying disability.

Time frame

15 weeks

3

Oxford Muscle Strength Score (Medical Research Council, MRC)

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).

Time frame

15 weeks

4

Vibration Score

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).

Time frame

15 weeks

Secondary outcomes

1

CIDP Score

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.

Time frame

1, 7, and 13 weeks

2

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

Standard clinical score for CIDP, quantifying disability.

Time frame

1, 7, and 13 weeks

3

Oxford Muscle Strength Score (Medical Research Council, MRC)

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).

Time frame

16 weeks

4

Vibration Score

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).

Time frame

16 weeks

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts