EUCTR2012-005086-12-DE
进行中（未招募）
不适用
Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
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
- •1\) Patients aged \=18 years
- •2\) Early diagnosed relapsing form of MS (\= 5years) according to the revised McDonald criteria (1\-3\)
- •3\) Patients who are at least 3 months on stable dosage of either IFN\-ß sc or GA and who did NOT receive the other first\-line therapy before
- •4\) Kurtzke’s EDSS \=3\.5
- •5\) Patients who experienced at least one medically confirmed relapse during the last 12 months or at least two such relapses in the last 24 months prior to study entry (but not within 30 days between last steroid treatment of relapse and start of screening;
- •subjects who relapse during the screening phase can be re\-screened, once the relapse has resolved but earliest 30 days after the end of relapse treatment with steroids) or at least 1 T1 Gd\+ lesion at screening
- •6\) Voluntarily given, fully informed written consent obtained from patient before any study\-related procedures are conducted
- •7\) Patient must be capable to understand and comply with the relevant aspects of the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •1\) Patients who have received treatment with immunoglobulins for any reason in the last 6 months
- •2\) Patients who have received immunosuppressive treatments such as azathioprine,
- •mitoxantrone, cyclophosphamide teriflunomide or fingolimod in the last 6 months
- •3\) Patients who have received rituximab or other immune cell depleting therapies in the last 18 months
- •4\) Treatment with steroids (oral or parenteral, long\-term, i.e. 30 days or more, not intermittent or burst, daily, \=0\.15 mg of prednisone or equivalent/kg/day ) except relapse treatment with corticosteroids
- •5\) Patients who have received monoclonal antibody therapy with natalizumab in the last 12 months
- •6\) Patients who have ever received monoclonal antibody therapies with alemtuzumab, daclizumab, or ocrelizumab
- •7\) Patients with severe renal function impairment as defined by serum creatinine values \>120 µmol/L
- •8\) Patients with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the patient has antibodies against IgA
- •9\) Patients with a history of deep vein thrombosis or thrombotic complications of IVIG therapy
研究者
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