NL-OMON37171已完成3 期
An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - FreedoMS extension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 89
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. Patients should complete the 24 month core study
- •2. Written informed consent provided prior to participation in extension study
- •3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
排除标准
- •1. Premature discontinuation of the study drug during the core study FTY720D2301 due
- •a. An adverse event or serious adverse event or laboratory abnormality, except
- •b. Conditions leading to permanent study drug discontinuation such as macular
- •edema, elevated liver enzymes five times ULN (upper limit of normal),
- •pulmonary function tests below 60% of baseline values. The full description of
- •these exclusion criteria and monitoring guidelines is outlined in Appendix 4:
- •Guidance on Safety Monitoring
- •2. Chronic disease of the immune system other than MS which may require
- •immunosuppressive treatment
- •3. History or presence of malignancy
- •4. Known diagnosis of diabetes mellitus or a blood glucose obtained suspicious for
- •diabetes (* 126 mg/dl or * 7 mmol/L if fasting; * 200 mg/dl or * 11.1 mmol/L if
- •5. Macular edema during the core study
- •6. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis
- •B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or
- •Hepatitis C antibody tests
- •7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone
- •8. Treatment with immunoglobulins and/or monoclonal antibodies (including
- •Natalizumab) in the past 3 months
- •9. Any medically unstable condition, that may interfere with the patient*s ability to
- •cooperate and comply with the study procedures, as assessed by the treating physician
- •10. Any of the following cardiovascular conditions:
- •a. myocardial infarction within the past 6 months prior to entry in the extension
- •study or with current unstable ischemic heart disease;
- •b. cardiac failure (Class III, according to New York Heart Association
- •Classification) or any severe cardiac disease as determined by the investigator;
- •c. arrhythmia requiring current treatment with Class III antiarrhythmic drugs
- •(e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
- •d. history or presence of a third degree AV block
- •This document (090095af80e8c6b5 in docbase CREDI_EH) has been digitally signed with external signatures using Entrust PKI.
- •Signatures manifested as of 11/9/2007 9:03:15 AM, signing status at this time: Completed (2 of 2 signatures)
- •Approved for report publication by Zhang Zheng in East Hanover at Fri, 09 Nov 2007 08:58:46 AM EST
- •Approved for report publication by Agoropoulou Aikaterini in Basel at Fri, 09 Nov 2007 11:22:31 CET
- •Novartis Confidential Page 13
- •Clinical Study Protocol CFTY720D2301E1
- •e. proven history of sick sinus syndrome or sino-atrial heart block
- •f. known history of angina pectoris due to coronary spasm or Raynaud*s
- •11. Any of the following pulmonary conditions:
- •a. Severe respiratory disease or pulmonary fibrosis diagnosed [during the core
- •b. History of tuberculosis
- •c. Abnormal chest x-ray or high resolution computer tomography (HRCT) [at
- •selected sites] suggestive of active pulmonary disease in the core study
- •12. Known history of alcohol abuse, chronic liver disease
- •13. Current participation in any clinical research study evaluating another investigational
- •drug or therapy
- •14. Female patients that are nursing (lactating)
研究者
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