NL-OMON47187已完成3 期
A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (CFTY720D2399- LONGTERMS) - CFTY720D2399
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 95
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
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Patients who have completed designated ongoing or planned Novartis global clinical
- •trials with fingolimod and are unable to obtain fingolimod outside a clinical trial.
排除标准
- •* Premature permanent discontinuation of a previous fingolimod study due to:
- •a. An adverse event or serious adverse event or laboratory abnormality.
- •b. Conditions leading to permanent study drug discontinuation such as macular edema, elevated liver enzymes five times ULN (upper limit of normal), malignancy of any organ system.
- •c. Unsatisfactory therapeutic result in the prceding fingolimod study (2 or more relapses per year as defined by the Dutch certified EC).
- •* Patients with a history of chronic disease of the immune system other than MS.
- •* Uncontrolled diabetes mellitus (HbA1c > 8%), certain forms of diabetic retinopathy.
- •* Patients with active systemic bacterial, viral or fungal infections. Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- •* Voorgaande behandeling met cladribine, cyclophosphamide of mitoxantrone.
- •* 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.
- •* Any of the following cardiovascular conditions that have developed during the previous fingolimod study: history of cardiac arrest, MI in the last 6 months, unstable ischemic heart disease, cardiac failure (NYHA Class III), patients receiving current treatment with Class III antiarrhythmic drugs, history or presence of second type II or third degree AV block or corrected QTc interval >450 msec in males and >470 msec in females, proven history of sick sinus syndrome or sino-atrial heart block, uncontrolled hypertension, resting heart rate <45 bom, angina pectoris due to coronary spasm or Raynaud*s phenomenon.
- •* Pulmonary fibrosis, active tuberculosis.
- •* Pregnancy, lactation, inadequate contraception.
- •Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy or nursing (lactating) can be re-enrolled.
研究者
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