NCT01709812撤回4 期
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-treated Patients With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- change in treatment satisfaction (TSQM-9) from baseline to month 6
研究概览
简要总结
A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in RRMS patients to assess the impact of an individualized patient support program (PSP) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for inclusion in this trial have to fulfill all of the following criteria:
- •Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
- •Male or female subjects aged 18 - 65 years.
- •Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.
- •Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).
排除标准
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •Patients, who are registered in any patient support program (e.g. Extracare)
- •Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
- •Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
- •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
- •Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
- •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)
- •Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details).
- •Simultaneous participation in another clinical trial.
- •Patients, who have already been randomized into this trial earlier must not be included a second time.
- •Study personnel or first degree relatives of investigator(s) must not be included in the study.
研究组 & 干预措施
1 standard care
Other
standard care
干预措施: Standard care (Other)
2 individualized PSP
Experimental
individualized patient support program
干预措施: individualized patient support program (Other)
结局指标
主要结局
change in treatment satisfaction (TSQM-9) from baseline to month 6
时间窗: 6 months
To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
次要结局
- change in Modified Morisky Scale score from baseline to month 6(6 months)
- change in mFIS score from baseline to month 6(6 months)
- change in BDI from baseline to month 6(6 months)
- quantification of therapy adherence (pill-count) over 6 months(6 months)
研究者
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