A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Merck Serono S.A. - Geneva0 个研究点目标入组 376 人开始时间: 2010年7月13日最近更新: 2015年8月17日

试验速览

暂无简介。

•Patients will be eligible to participate in this study if they meet all of the following criteria:
•1. Completed 26 weeks of double-blind phase of Study ONO-4641POU006
•2. For females:
•a. Patients of childbearing potential who agree to use an acceptable form of birth control (i.e. double barrier method; diaphragm plus condom, intrauterine device plus condom, hormonal contraception plus condom, spermicidal gel plus condom, or abstinence) throughout the study and until 2 months after the last dose;
•b. Negative serum and urine human chorionic gonadotropin (hCG) assay at Visit 9;
•3. For males:
•a. Agree to use a condom with spermicide when engaging in sexual intercourse during participation in the study and until 2 months after the last dose;
•b. Agree to refrain from sperm donation during participation in the study and until 2 months after the last dose;
•4. Able and willing to provide signed, written, Informed Consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 376
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Patients will not be eligible to participate in this study if any of the following criteria apply:
•1. Presence of any dermatological abnormalities during Study ONO-4641POU006 that in the opinion of the investigator or the Sponsor (Ono Pharmaceutical Co., Ltd.) could increase the risk of the patient developing a skin cancer;
•2. In the opinion of the Investigator, a patient who may not be able to cooperate fully with the study staff, may have difficulty in some study requirements, or is otherwise not qualified for the study.

发起方

Merck Serono S.A. - Geneva