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临床试验/NCT02465359
NCT02465359已完成不适用

A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy

University of South Florida1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms

研究概览

简要总结

The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.

详细描述

Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological disorder that causes limb weakness and numbness. Many patients require immunosuppressants and plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG) is also an effective treatment (Hughes et al, 2006 & 2008; Hughes, 2009; Cocito et al, 2010), and the American Academy of Neurology (AAN) guideline recommended that it should be offered in the long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003). As compared to intravenous (IV) route, SC route maintains higher trough levels of immunoglobulins, increases patient independence, reduces systemic side-effects, and is better tolerated in those who are pregnant or sensitized to Immunoglobulin A (IgA) (Radinsky et al, 2003). In a review of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in Canada showed that the mean difference in costs between IVIG and SCIG during the study period (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A US$10,100 reduction in cost per year per patient associated with SCIG use was also reported by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and local reactions at sites of infusion (transient swelling, soreness, redness, induration, local heat, and itching) in about 1% of patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or more of the following):
  • Weakness in any limb,
  • Motor fatigue significant to interfere with activities of daily living (ADL) or work,
  • Paresthesia of sufficient severity to require a medication,
  • Sensory impairment,
  • Walking impairment,
  • AND requires IVIG to control symptoms.

排除标准

  • Thrombocytopenia or other bleeding disorders,
  • Anticoagulation therapy,
  • Severe or anaphylactoid reactions to IVIG,
  • Breast-feeding,
  • Renal insufficiency or failure,
  • Congestive heart failure,
  • Psychiatric illness.

研究组 & 干预措施

Immune globulin subcutaneous (Human)

Experimental

lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly

干预措施: Immune Globulin Subcutaneous (Human) (Drug)

结局指标

主要结局

Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms

时间窗: 24 weeks

This outcome measure, referred to as the relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms, is a measure of how many participants experiences CIDP symptoms causing them to withdraw prematurely from the study. This is a count of participant withdrawals compared to the number of participants who completed the study.

次要结局

  • Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening(24 weeks)
  • Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24(24 weeks)
  • Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening(24 weeks)
  • Treatment Satisfaction Questionnaire for Medication (TSQM)(24 weeks)
  • Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24(24 weeks)
  • Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening)(24 weeks)
  • Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24(24 weeks)
  • Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks(24 weeks)
  • Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24(24 weeks)
  • Mean Change in Short Form 36 Domain: Pain Between Screening and 24 Weeks(24 weeks)
  • Mean Change in Short Form 36 Domain "General Health" Between Screening and Week 24(24 weeks)
  • Mean Change in Limb Motor Strength Testing (LMST) Over 24 Weeks(24 weeks)
  • Mean Change in Timed 25-foot Walk (T25-FW) Between Screening and Week 24(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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