EUCTR2008-004579-22-DE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 efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis
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 (with IFN-beta or glatiramer acetate) are contraindicated or not tolerated.
- •Kurtzke's EDSS between 0 and 3.5 (0 <= 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
- •- who have received treatment with immunoglobulins for any reason previously.
- •- who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.
- •- 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.
- •- who have received any monoclonal antibody therapies (e.g. natalizumab) previously.
- •- who had a relaspe within 3 months prior to study entry.
- •- with severe renal function impairment as defined by serum creatinine values > 24 mg/L.
- •- with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.
- •- with a body weight > 120 kg.
- •- with a history of anaphylaxis after previous transfusions of blood or blood products.
- •- for whom MRI is contraindicated or who are allergic to gadolinium.
- •- being pregnant or lactating.
- •- who delivered a baby within 12 months before study entry (including miscarriage, stillbirth, abortion).
- •- with a diagnosis of severe depression.
- •- with known chronic infectious diseases or malignant disease.
- •- with known antibody deficiencies or other autoimmune diseases other than MS.
- •- 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.
研究者
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