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| Name | Class |
|---|---|
| Miltenyi Biomedicine GmbH | INDUSTRY |
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This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption | Experimental | 3 cycles of immunoadsorption in week 1, 7, and 13 after randomization. One cycle consists of 5 sessions on 5 consecutive days with processing of the 2-fold plasma volume on the first day and the 2.5-fold plasma volume on consecutive days, using regenerative adsorbers (Therasorb, Miltenyi Biotec, Bergisch Gladbach) |
|
| Immunoglobulins | Active Comparator | 5 cycles of intravenous immunoglobulins in week 1, 4, 7, 10, and 13 after randomization. The first cycle consists of 5 intravenous applications of immunoglobulins on 5 consecutive days in a dosage of 0.4 g per kg body weight per day. Subsequent cycles consist of 2 intravenous applications of immunoglobulins on 2 consecutive days in a dosage of 0.5 g per kg body weight per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoadsorption | Device | see arm/group description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 weeks |
| Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | Standard clinical score for CIDP, quantifying disability. | 15 weeks |
| 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). | 15 weeks |
| 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). | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 7, and 13 weeks |
| Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Dorst, Prof | Contact | +49 731 177 5285 | johannes.dorst@uni-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Dorst, Prof | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
3 months after publication until 5 years after publication
Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| D007136 | Immunoglobulins |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| Immunoglobulins |
| Biological |
see arm/group description |
|
Standard clinical score for CIDP, quantifying disability. |
| 1, 7, and 13 weeks |
| 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). | 16 weeks |
| 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). | 16 weeks |
| Pain | Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain). | 1, 7, 13, and 15 weeks |
| N20 Latency | N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs). | 15 weeks |
| P40 Latency | P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs). | 15 weeks |
| Nerve Conduction Velocity | Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG). | 15 weeks |
| Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L) | Quality of Life Scale | 1, 7, 13, and 15 weeks |
| Immunoglobulin A | Immunoglobulin A serum levels | 1, 7, 13, and 15 weeks |
| Immunoglobulin G | Immunoglobulin G serum levels | 1, 7, 13, and 15 weeks |
| Immunoglobulin M | Immunoglobulin M serum levels | 1, 7, 13, and 15 weeks |
| Interleukin-1 | Interleukin-1 serum levels | 1, 7, 13, and 15 weeks |
| Interleukin-6 | Interleukin-6 serum levels | 1, 7, 13, and 15 weeks |
| Anti-contactin-1 | Anti-contactin-1 serum levels | 1, 7, 13, and 15 weeks |
| Anti-neurofascin155 | Anti-neurofascin155 serum levels | 1, 7, 13, and 15 weeks |
| Anti-contactin-associated-protein1 | Anti-contactin-associated-protein1 serum levels | 1, 7, 13, and 15 weeks |
| Anti-neurofascin186 | Anti-neurofascin186 serum levels | 1, 7, 13, and 15 weeks |
| Anti-neurofascin140 | Anti-neurofascin140 serum levels | 1, 7, 13, and 15 weeks |
| Neurofilament Light Chain (NfL) | Neurofilament light chain (NfL) serum levels | 1, 7, 13, and 15 weeks |
| Therapeutic Response | Share of patients with at least 10% improvement in CIDP score compared to baseline. | 15 weeks |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |