Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
概览
- 阶段
- 2 期
- 干预措施
- Immunoadsorption
- 疾病 / 适应症
- CIDP
- 发起方
- University of Ulm
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
- 状态
- 招募中
- 最后更新
- 昨天
概览
简要总结
This is a randomized controlled study evaluating safety and efficacy of repeated immunoadsorption versus immunoglobulins in steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
研究者
Albert Christian Ludolph, Prof.
Prof. Dr.
University of Ulm
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Immunoadsorption
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.
干预措施: Immunoglobulins
结局指标
主要结局
Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
时间窗: 15 weeks
Standard clinical score for CIDP, quantifying disability.
CIDP Score
时间窗: 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.
Oxford Muscle Strength Score (Medical Research Council, MRC)
时间窗: 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
时间窗: 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).
次要结局
- Neurofilament Light Chain (NfL)(1, 7, 13, and 15 weeks)
- Nerve Conduction Velocity(15 weeks)
- Immunoglobulin A(1, 7, 13, and 15 weeks)
- Interleukin-6(1, 7, 13, and 15 weeks)
- Anti-neurofascin155(1, 7, 13, and 15 weeks)
- Anti-contactin-associated-protein1(1, 7, 13, and 15 weeks)
- CIDP Score(1, 7, and 13 weeks)
- Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score(1, 7, and 13 weeks)
- Pain(1, 7, 13, and 15 weeks)
- Euro Quality of Life 5 Dimension 5 Levels (EQ-5D-5L)(1, 7, 13, and 15 weeks)
- Interleukin-1(1, 7, 13, and 15 weeks)
- Immunoglobulin M(1, 7, 13, and 15 weeks)
- Anti-contactin-1(1, 7, 13, and 15 weeks)
- Anti-neurofascin140(1, 7, 13, and 15 weeks)
- Therapeutic Response(15 weeks)
- Oxford Muscle Strength Score (Medical Research Council, MRC)(16 weeks)
- N20 Latency(15 weeks)
- P40 Latency(15 weeks)
- Vibration Score(16 weeks)
- Immunoglobulin G(1, 7, 13, and 15 weeks)
- Anti-neurofascin186(1, 7, 13, and 15 weeks)