ISRCTN57377482已完成不适用
A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg assay panel and the B-Cell/antibody response panel to predict the clinical effect of Octagam® 5% in subjects with relapsing/remitting multiple sclerosis
Octapharma AG (Switzerland)0 个研究点目标入组 30 人开始时间: 2009年3月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects aged greater than or equal to 18 years, either sex
- •2. Multiple sclerosis (MS) according to the revised McDonald criteria
- •3. Relapsing-remitting form of MS
- •4. First-line disease modifying treatments (interferon-beta [IFN-beta] or glatiramer acetate) are contraindicated or not tolerated
- •5. Kurtzke's Expanded Disability Status Scale (EDSS) between 0 and 3.5 (0 to less than 3.5)
- •6. Subjects who experienced at least one relapse during the last 12 months or at least two relapses in the last 24 months prior to study entry
- •7. Freely given, fully informed written consent obtained from subject
排除标准
- •1. Subjects who have received treatment with immunoglobulins for any reason previously
- •2. Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids
- •3. Subjects who have received disease modifying first-line treatments with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks
- •4. Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously
- •5. Subjects who had a relapse within 3 months prior to study entry
- •6. Subjects with severe renal function impairment as defined by serum creatinine values greater than 24 mg/l
- •7. Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA
- •8. Subjects with a body weight of greater than 120 kg
- •9. Subjects with a history of anaphylaxis after previous transfusions of blood or blood products
- •10. Subjects for whom magnetic resonance imaging (MRI) is contraindicated or who are allergic to gadolinium
- •11. Pregnant or lactating women
- •12. Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth)
- •13. Subjects with a diagnosis of significant depression
- •14. Subjects with known chronic infectious diseases or malignant disease
- •15. Subjects with known antibody deficiencies or other autoimmune diseases other than MS
- •16. Subjects participating in another study during the course of this study or during the past 6 months or who have ever participated in a study investigating in new disease modifying or immunosuppressive drugs
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