EUCTR2015-002500-91-IT进行中（未招募）1 期
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study
CELGENE INTERNATIONAL II SàR0 个研究点目标入组 2,496 人开始时间: 2021年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,496
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
- •To be eligible to participate in this trial, patients must meet all of the
- •following criteria:
- •1. Completed one of the parent trials
- •2. Does not have a condition that would require withdrawal from one of the parent trials
- •3. Has no conditions requiring treatment with a prohibited concomitant medication
- •4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe: At Baseline (Day 1) CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg,
- •rifampicin) Two weeks prior to Baseline (Day 1) Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
- •5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •6. Female patients of childbearing potential: Must agree to practice a highly effective method of contraception
- •throughout the study until completion of the 90-day Safety Follow-Up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
- •Acceptable methods of birth control in this study are the following:
- •-Combined hormonal (oestrogen and progestogen containing)
- •contraception, which may be oral, intravaginal, or transdermal
- •-Progestogen-only hormonal contraception associated with inhibition of
- •ovulation, which may be oral, injectable, or implantable
- •-Placement of an intrauterine device (IUD)
- •-Placement of an intrauterine hormone-releasing system (IUS)
- •-Bilateral tubal occlusion
- •-Vasectomised partner
- •-Sexual abstinence
- •All patients: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
- •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 2496
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
研究者
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