IVITOC: Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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) |
Device: Immunoadsorption
see arm/group description
|
| Active Comparator: 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. |
Biological: Immunoglobulins
see arm/group description
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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).
- 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
- Interleukin-1 [1, 7, 13, and 15 weeks]
Interleukin-1 serum levels
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, University of Ulm | Ulm | Baden-Württemberg | Germany | 89081 |
Sponsors and Collaborators
- University of Ulm
- Miltenyi Biomedicine GmbH
Investigators
- Principal Investigator: Johannes Dorst, Prof, University of Ulm
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IVITOC 1.1