EUCTR2012-002637-11-DE进行中（未招募）不适用
A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAY
ovartis Pharma GmbH0 个研究点开始时间: 2012年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •1.Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
- •2.Male or female subjects aged 18 – 65 years.
- •3.Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
- •4.Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
- •5.Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients, who are registered in any patient support program (e.g. Extracare)
- •2.Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
- •3.Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator’s discretion
- •4.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •5.Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
- •6.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum)
- •7.Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.9.5 for details).
- •8.Simultaneous participation in another clinical trial.
研究者
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