NL-OMON38164已完成3 期
A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient with relapsing forms of multiple sclerosis (MS) treated with Interferon beta (IFN-β) defined by:
- •- Stable dose of IFN-β for at least 6 months prior to randomization,and
- •- Disease activity in the 12 months prior to randomization and after first 3 months of IFN-β treatment (at least one relapse supported by Expanded Disability status Scale (EDSS) or equivalent neurological examination, or, at least one brain or spinal cord Magnetic Resonance Imaging (MRI) with at least one T1 gadolinium enhancing lesion).
排除标准
- •< 18 years of age or >= 56 years of age.
- •McDonald*s criteria for MS diagnosis not met at time of screening visit.
- •EDSS score > 5.5 at randomization visit.
- •A relapse within 30 days prior randomization.
- •Human Immunodeficiency Virus (HIV) positive patient.
- •Prior use within 6 months preceding randomization or concomitant use of nataluzimab and any other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate or fingolimod.
- •Prior use in the 3 months preceding randomization of cytokine therapy (except baseline IFN-β), glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments.
- •Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone.
- •Pregnant or breast-feeding women or those who plan to become pregnant during the study.
研究者
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