Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score |
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted |
2 weeks |
|
Primary |
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score |
Standard clinical score for inflammatory neuropathies. |
2 weeks |
|
Primary |
Oxford Muscle Strength Score (Medical Research Council, MRC) |
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity). |
2 weeks |
|
Primary |
Vibration Score |
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides). |
2 weeks |
|
Secondary |
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score |
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted |
1, 3, and 5 weeks |
|
Secondary |
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score |
Standard clinical score for inflammatory neuropathies. |
1, 3, and 5 weeks |
|
Secondary |
Oxford Muscle Strength Score (Medical Research Council, MRC) |
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity). |
1, 3, and 5 weeks |
|
Secondary |
Vibration Score |
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides). |
1, 3, and 5 weeks |
|
Secondary |
Hughes Score |
Standard clinical score to quantify disability in Guillain-Barré syndrome |
1, 2, 3, and 5 weeks |
|
Secondary |
Pain |
Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain). |
1, 2, 3, and 5 weeks |
|
Secondary |
N20 |
N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs) |
2 and 5 weeks |
|
Secondary |
P40 |
P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials |
2 and 5 weeks |
|
Secondary |
Nerve Conduction Velocity |
Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG) |
2 and 5 weeks |
|
Secondary |
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) |
Quality of Life Scale |
1, 2, 3, and 5 weeks |
|
Secondary |
Immunoglobulin A in serum |
Immunoglobulin A serum concentration |
1, 2, 3, and 5 weeks |
|
Secondary |
Immunoglobulin A in cerebrospinal fluid (CSF) |
Immunoglobulin A concentration in cerebrospinal fluid |
2 weeks |
|
Secondary |
Immunoglobulin G in serum |
Immunoglobulin G serum concentration |
1, 2, 3, and 5 weeks |
|
Secondary |
Immunoglobulin G in cerebrospinal fluid (CSF) |
Immunoglobulin G concentration in cerebrospinal fluid |
2 weeks |
|
Secondary |
Immunoglobulin M in serum |
Immunoglobulin M serum concentration |
1, 2, 3, and 5 weeks |
|
Secondary |
Immunoglobulin M in cerebrospinal fluid (CSF) |
Immunoglobulin M concentration in cerebrospinal fluid |
2 weeks |
|
Secondary |
Interleukin-1 |
Interleukin-1 serum concentration |
1, 2, 3, and 5 weeks |
|
Secondary |
Interleukin-6 |
Interleukin-6 serum concentration |
1, 2, 3, and 5 weeks |
|
Secondary |
Anti-GM1 antibodies |
Anti-GM1 antibody serum levels |
1, 2, 3, and 5 weeks |
|
Secondary |
Anti-GQ1b |
Anti-GQQ1b antibody serum levels |
1, 2, 3, and 5 weeks |
|
Secondary |
Neurofilament light chain (NfL) serum |
Neurofilament light chain (NfL) serum levels |
1, 2, 3, and 5 weeks |
|
Secondary |
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF) |
Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF) |
2 weeks |
|
Secondary |
Safety and Tolerability |
Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
1, 2, 3, and 5 weeks |
|
Secondary |
Therapeutic Response |
Share of patients with at least 20% improvement in CIDP score |
1, 2, 3, and 5 weeks |
|