NL-OMON36707已完成3 期
A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis (CFTY720D2316) - CFTY720D2316
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 57
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
- •* Male or female subjects aged 18-65 years.
- •* Subjects with relapsing forms of MS.
- •* EDSS score 0-6.5.
排除标准
- •* Patients with a history of chronic disease of the immune system other than MS.
- •* Uncontrolled diabetes mellitus (HbA1c > 7%).
- •* Diagnosis of macular edema during Screening Phase.
- •* Patients with active systemic bacterial, viral or fungal infections. Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- •* Negative for varicella-zoster virus IgG antibodies at Screening.
- •* Have received any live or live attenuated vaccines within 1 month prior to baseline.
- •* Corticosteroids or ACTH within 1 month prior to baseline.
- •* Immunosuppressive medications within 3 months prior to baseline.
- •* Immunoglobulins and/or monoclonal antibodies within 3 months prior to baseline.
- •* Cladribine, cyclophosphamide or mitoxantrone at any time.
- •* Patients with impaired cardiovascular condition and/or findings in the screening ambulatory 24-hour ECG-recording (see protocol for details).
- •* Pulmonary fibrosis.
- •* Abnormal liver conditions (see protocol for details).
- •* Pregnancy, lactation, inadequate contraception.
研究者
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