EUCTR2014-000395-26-DE进行中（未招募）1 期
A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biogen GmbH
- 入组人数
- 600
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 18-64 years.
- •3. Subjects with a) relapsing remitting MS (RRMS) defined by 2010 revised McDonald (Polman et al., 2011) criteria OR b) early MS (100 patients, reference cohort)
- •a) Patients with diagnosis of RRMS must satisfy the approved therapeutic indication for dimethyl fumarate (DMF) (as per local SmPC) and must have been clinically stable on DMF for at least 4 and up to 16 weeks prior to screening visit
- •b) Patients in the reference cohort must have had a single neurological episode within 60 months before screening.
- •They have to be without immunomodulatory treatment at screening.
- •They must not have a progressive form of MS.
- •Patients for the reference cohort may be evaluated also retrospectively at selected sites if they have given full informed consent.
- •The following data have to be recorded or available for these reference patients:
- •- Demography
- •- Neurological examination / EDSS
- •- Visual acuity (BCVA)
- •4. Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5 (including).
- •5. RNFLT at screening (for RRMS patients) must be at least 84µm and high contrast ETDRS visal acuity >0.5 in at least one eye (OCT has to be confirmed by Central Reading Center). For reference patients criteria have to be fulfilled at time of first documented OCT measurement.
- •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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
- •2. Patients that have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
- •3. 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 hCG test (urine dipstick).
- •4. Women of childbearing potential and not using appropriate contraception (per local DMF SmPC) as determined by the Investigator.
- •5. Patients with known hypersensitivity to the active ingredient in the DMF drug product or to any of the excipients listed in the local DMF SmPC (for the RRMS cohort).
- •6. Patients with a contraindication to DMF according to SmPC (for the RRMS cohort)
- •7. Patients with an onset of acute optic neuritis within the last 3 months.
- •8. Patients with an MS relapse within the last 30 days
- •9. Concomitant use of drugs that may directly affect retinal structure and function (e.g. chronic systemic corticosteroids).
- •10. Patients with any ophthalmologic reason for RNFL pathology other than MS, such as: optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist’s clinical judgment.
- •11. Patients with evidence of advanced, non-proliferative or proliferative diabetic retinopathy.
- •12. Patients with presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
- •13. Patients with history or presence of severe myopia (> - 6 dpt).
- •14. Patients who participate in another interventional study.
- •15. Patients who are institutionalized by court or official order
研究者
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