Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Conditions
- CIDP
- Interventions
- Device: ImmunoadsorptionBiological: Immunoglobulins
- Registration Number
- NCT04881682
- Lead Sponsor
- University of Ulm
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immunoadsorption Immunoadsorption 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 Immunoglobulins 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pain 1, 7, 13, and 15 weeks Quantifying pain on a Visual Analog Scale between 0 (no pain) and 10 (maximum pain).
Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L) 1, 7, 13, and 15 weeks Quality of Life Scale
Anti-neurofascin140 1, 7, 13, and 15 weeks Anti-neurofascin140 serum levels
P40 Latency 15 weeks P40 latency of Nervus tibialis (both sides) in somatosensory evoked potentials (SEPs).
Neurofilament Light Chain (NfL) 1, 7, 13, and 15 weeks Neurofilament light chain (NfL) serum levels
Nerve Conduction Velocity 15 weeks Nerve conduction velocities of clinically affected nerves as measured by electroneurography (ENG).
Immunoglobulin A 1, 7, 13, and 15 weeks Immunoglobulin A serum levels
Interleukin-6 1, 7, 13, and 15 weeks Interleukin-6 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
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.
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score 1, 7, and 13 weeks Standard clinical score for CIDP, quantifying disability.
Interleukin-1 1, 7, 13, and 15 weeks Interleukin-1 serum levels
Immunoglobulin M 1, 7, 13, and 15 weeks Immunoglobulin M serum levels
Anti-contactin-1 1, 7, 13, and 15 weeks Anti-contactin-1 serum levels
Therapeutic Response 15 weeks Share of patients with at least 10% improvement in CIDP score compared to baseline.
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).
N20 Latency 15 weeks N20 latency of Nervus medianus (both sides) in somatosensory evoked potentials (SEPs).
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).
Immunoglobulin G 1, 7, 13, and 15 weeks Immunoglobulin G serum levels
Anti-neurofascin186 1, 7, 13, and 15 weeks Anti-neurofascin186 serum levels
Trial Locations
- Locations (1)
Department of Neurology, University of Ulm
🇩🇪Ulm, Baden-Württemberg, Germany