EUCTR2010-018705-11-DE进行中（未招募）不适用
A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 376
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. From participation and throughout the duration of the study, male and female subjects of childbearing potential (ie, non-sterilized, premenopausal females) who are sexually active must use adequate contraception until 2 months after the last dose of study medication. An acceptable method of contraception is defined as one that has no failure rate or a <1% failure rate. It is recommended to combine a hormonal method (PEARL index < 1) with a barrier method. The following contraception methods are especially reliable according to the guidelines of the German Association of Gynaecology and Obstetrics:
- •Oral contraceptive pill with estrogen and gestagen (no micro pill)
- •Vaginal ring (i.e.. NuvaRing®)
- •Contraception plaster (i.e. EVRA®)
- •Estrogen-free ovulation inhibitor (i.e. Cerazette®)
- •Intradermal contraception sticks with progesteron (i.e. Implanon®)
- •an injection of gestagen every 3 months
- •Contraceptive coil with Progesteron (i.e. Minera®)
- •Contraception with double barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal gel or foam)
- •Male subjects and women of child bearing potential will be provided with information on acceptable methods of contraception as part of the subject informed consent process, and will be advised of the requirements for avoidance of pregnancy until 2 months after the last dose of study medication. Subjects will receive continued guidance with respect to the avoidance of pregnancy as part of the study procedures. In addition to a negative serum hCG pregnancy test throughout the study period, subjects also must have a negative urine hCG pregnancy test on the day of the first dose of study medication, prior to receiving the first dose of the extension study drug.
- •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
排除标准
- •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.
- •3. Any of the following cardiovascular conditions:
- •a. History of significant cardiac (e.g. coronary heart disease, myocarditis, cardiomyopathy, heart failure NYHA II-IV) condition;
- •b. History of syncope;
- •c. Resting heart rate < 55 beat/min based on ECG at Visit 9 predose or history of any cardiac conditions that might increase the risk of a significant reduction in heart rate (e.g. any delay in the cardiac stimulus conduction on ECG);
- •d. Any medical condition that poses a significant risk of predisposing a patient to induction of cardiac arrhythmias (e.g. status post catheter ablation, hyperkalemia [defined as 2 consecutive measures of K+ above 6.0 mEq/L]).
研究者
相似试验
进行中（未招募）
不适用
A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISEUCTR2010-018705-11-GRONO Pharmaceutical Co., Ltd.376
进行中（未招募）
不适用
A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISRelapsing-remitting Multiple SclerosisMedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-018705-11-CZMerck KGaA376
进行中（未招募）
不适用
A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSISEUCTR2010-018705-11-BEMerck Serono S.A. - Geneva376
未知
2 期
A Safety and Efficacy Extension Study of ONO-4641 in Patients with Relapsing-Remitting Multiple SclerosisJPRN-jRCT2080221270ONO PHARMACEUTICAL CO.,LTD.343
终止
2 期
Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple SclerosisNCT01226745EMD Serono340