EUCTR2008-004579-22-AT进行中（未招募）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 (RR) multiple sclerosis (MS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Subjects aged = 18 years.
- •MS according to the revised McDonald criteria.
- •Relapsing-remitting form of MS.
- •First-line disease modifying treatments (IFN-beta or glatiramer acetate) are contraindicated or not tolerated.
- •Kurtzke’s EDSS between 0 and 3.5 (0 to <= 3.5).
- •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.
- •Freely given, fully informed written consent obtained from subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who have received treatment with immunoglobulins for any reason previously.
- •Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.
- •Subjects who have received disease modifying first-line treatments treatment with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks.
- •Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously.
- •Subjects who had a relapse within 3 months prior to study entry.
- •Subjects with severe renal function impairment as defined by serum creatinine values > 24 mg/L.
- •Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.
- •Subjects with a body weight of >120 kg.
- •Subjects with a history of anaphylaxis after previous transfusions of blood or blood products.
- •Subjects for whom MRI is contraindicated or who are allergic to gadolinium. Pregnant or lactating women.
- •Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth).
- •Subjects with a diagnosis of significant depression.
- •Subjects with known chronic infectious diseases or malignant disease.·Subjects with known antibody deficiencies or other autoimmune diseases other than MS.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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