CIDP
Conditions
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).
Interventions
DEVICEImmunoadsorption
see arm/group description
BIOLOGICALImmunoglobulins
see arm/group description
Sponsors
Miltenyi Biomedicine GmbH
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIDP Score | 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. |
| Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 15 weeks | Standard clinical score for CIDP, quantifying disability. |
| Oxford Muscle Strength Score (Medical Research Council, MRC) | 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). |
| Vibration Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain | 1, 7, 13, and 15 weeks | Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain). |
| N20 Latency | 15 weeks | N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs). |
| P40 Latency | 15 weeks | P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs). |
| Nerve Conduction Velocity | 15 weeks | Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG). |
| Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L) | 1, 7, 13, and 15 weeks | Quality of Life Scale |
| Immunoglobulin A | 1, 7, 13, and 15 weeks | Immunoglobulin A serum levels |
| Immunoglobulin G | 1, 7, 13, and 15 weeks | Immunoglobulin G serum levels |
| Immunoglobulin M | 1, 7, 13, and 15 weeks | Immunoglobulin M serum levels |
| CIDP Score | 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. |
| Interleukin-6 | 1, 7, 13, and 15 weeks | Interleukin-6 serum levels |
| Anti-contactin-1 | 1, 7, 13, and 15 weeks | Anti-contactin-1 serum levels |
| Anti-neurofascin155 | 1, 7, 13, and 15 weeks | Anti-neurofascin155 serum levels |
| Anti-contactin-associated-protein1 | 1, 7, 13, and 15 weeks | Anti-contactin-associated-protein1 serum levels |
| Anti-neurofascin186 | 1, 7, 13, and 15 weeks | Anti-neurofascin186 serum levels |
| Anti-neurofascin140 | 1, 7, 13, and 15 weeks | Anti-neurofascin140 serum levels |
| Neurofilament Light Chain (NfL) | 1, 7, 13, and 15 weeks | Neurofilament light chain (NfL) serum levels |
| Therapeutic Response | 15 weeks | Share of patients with at least 10% improvement in CIDP score compared to baseline. |
| Interleukin-1 | 1, 7, 13, and 15 weeks | Interleukin-1 serum levels |
| Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 1, 7, and 13 weeks | Standard clinical score for CIDP, quantifying disability. |
| Oxford Muscle Strength Score (Medical Research Council, MRC) | 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). |
| Vibration Score | 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). |
Countries
Germany
Contacts
Primary ContactJohannes Dorst, Prof
Outcome results
None listed