EUCTR2014-001290-14-RO进行中（未招募）1 期
Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™ - PROCEED
MERCK ROMANIA SR0 个研究点开始时间: 2017年3月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Males and females between 18 to 65 years of age
- •Female patients must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
- •Post-menopausal or surgically sterile, or
- •Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner.
- •Patients diagnosed with clinical isolated syndrome (CIS) or relapsing MS (RMS) according to the revised McDonald Criteria (2010).
- •MS-treatment naïve patients or patients treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
- •Patients that are able to self-inject with RebiSmart™ (in the opinion of the physician)
- •Patients with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline
- •Informed consent and patient data collection form signed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients experiencing a relapse within 30 days before Baseline
- •Participation in other studies within 30 days before Baseline
- •Received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™.
- •Any visual or physical impairment that precludes the patient from self-injecting the treatment using the RebiSmart™
- •Pregnancy and breast-feeding
- •Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure.
- •Current or past (within the last 2 years) history of alcohol or drug abuse.
- •Have any contraindications to treatment with interferon beta-1a according to Summary of Product Characteristics
研究者
相似试验
招募中
Unknown
Prospective Clinical Trial for Evaluation of Efficacy of AI Assistant System in Breast Cancer ScreeningNeoplasmsKCT0009007ational Cancer Center3,057
招募中
4 期
A clinical trial to study the safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of hypertension.CTRI/2016/11/007424Sun Pharmaceutical Industries Limited
进行中（未招募）
1 期
utility study of a predictive system for ambulatory colonoscopy preparatioEUCTR2017-000787-15-ESAntonio Zebenzui Gimeno García300
招募中
2 期
Prospective clinical trial to evaluate the efficacy of acetazolamide for the treatment of cystoid macular edema in inherited retinal dystrophies: the CAR trialInherited retinal dystrophiesInhertited retinal diseases10047060NL-OMON51635Amsterdam UMC18
进行中（未招募）
不适用
A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of ZOSTAVAX™ in Subjects 50 to 59 Years of Age - ZOSTAVAX™ in Subjects 50 to 59 Years of AgeMedDRA version: 9.1Level: LLTClassification code 10019974Term: Herpes zosterHerpes ZosterEUCTR2007-004020-20-FIMSD Finland20,300