NCT04589299招募中4 期
Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Change in disability
研究概览
简要总结
SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.
详细描述
In fase I the patients are followed for 26 weeks on a fixed dose of 0.54 g/kg/week in the SCIG group (total 14 g/kg) and 2 g/kg/4week in the IVIG group (total 14 g/kg). The patients automatically continue in fase II in which treatment is reduced every 12 weeks (90%, 75%, 50%, 25% and 0%) over a course 60 weeks. The patients are evaluated at every visit with overall disability sum score (ODSS), grip strength, medical research council score (MRC-score), INCAT-Sensory Sum Score (ISS), 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), quality of life (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Life Quality Index (LQI) and blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling EFNS/PNS criteria for definite, probable or pure motor CIDP.
- •No previous treatment with IVIG or SCIG.
- •ODSS ≥ 2 - either (arm/leg): 1/1, 2/0 or 0/2 at the time of inclusion.
- •Clinical criteria for typical CIDP
- •Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected.
- •Absent or reduced tendon reflexes in all extremities.
- •Criteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP.
- •Electrophysiological criteria for CIDP
- •Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or
- •Reduction of motor conduction velocity ≥30% below LLN in two nerves, or
- •Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or
- •Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes ≥20% of LLN + ≥1 other demyelinating parameter in ≥1 other nerve, or
- •Partial motor conduction block: ≥50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP >20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve, or
- •Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or
- •Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in ≥1 nerve (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms) + ≥1 other demyelinating parameter in ≥1 other nerve
- •Electrophysiological criteria for probable CIDP
- •(a) ≥30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP ≥20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve
排除标准
- •Other causes of neuropathy
- •Increased risk of thromboembolism
- •Pregnancy (Plasma HCG is tested at inclusion in all fertile women)
- •Breast feeding
- •Malignancy
- •Severe medical disease
- •Other immune modulating treatment than low dose steroid (prednisolon < 25 mg daily) within the last 6 months prior to inclusion
- •Hepatitis B or C or HIV infection (screening at inclusion)
- •Known IgA deficiency
- •Known allergy to consents in PRIVIGEN or HIZENTRA
- •Body weight > 120 kg
- •After treatment initiation:
- •Pregnancy
- •Serious medical disease that affects treatment or examinations
- •Non-compliance to treatment
- •Initiation of other immune modulating therapy
- •Unacceptable side effects
- •Withdrawal of consent to participate (drop-out)
结局指标
主要结局
Change in disability
时间窗: Week 0 to 26
Evaluated with overall disability sum score (ODSS)
次要结局
- Change in sensation(Week 0 to 26)
- Change in walking performance(Week 0 to 26)
- Change in pain severity(Week 0 to 26)
- Change in dexterity(Week 0 to 26)
- Serum samples(Week 0 to 26)
- Fluctuations in the describing parameters (ODSS and RODS) in both groups (SCIG and IVIG) based on measurement at time points for treatment with IVIG(Week 0 to 26)
- Change in general muscle strength(Week 0 to 26)
- Change in quality of life(Week 0 to 26)
- Change in disability(Week 0 to 26)
- Change in grip strength(Week 0 to 26)
- Change in fatigue severity(Week 0 to 26)
- Change in treatment satisfaction(Week 2 to 26)
- Change in walking performance and imbalance(Week 0 to 26)
研究者
研究点 (8)
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