EUCTR2012-000674-31-DE进行中（未招募）1 期
A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya®
ovartis Pharma GmbH0 个研究点目标入组 87 人开始时间: 2012年4月27日最近更新:
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
- 入组人数
- 87
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 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 (see Appendix 4).
- •4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive (see Appendix 6).
- •5. Patients stable on immunomodulatory treatment with fingolimod for at least 1 month* and at most 4 months* prior to screening according to local label
- •6. Neurologically stable with no evidence of relapse within 30 days prior to inclusion date (visit 2)
- •7. Sufficient ability to read, write, communicate and understand
- •* one month is defined as 28 days
- •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
- •1. Patients who have been treated with:
- •systemic corticosteroids or immunoglobulins within 1 month* prior to screening;
- •immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months* prior to screening;
- •monoclonal antibodies (including natalizumab) within 3 months* prior to screening;
- •mitoxantrone within 6 months* prior to screening
- •cladribine at any time.
- •2. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- •3. Patients with any of the following cardiovascular conditions :
- •history of myocardial infarction or with current unstable ischemic heart disease;
- •Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the
- •Investigator (see Appendix 5);
- •history or presence of a second-degree AV block, Type II or a third-degree AV
- •patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
- •III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
- •dofelitide);
- •proven history of sick sinus syndrome;
- •uncontrolled hypertension
- •4. Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive
- •pulmonary disease (Class III-IV).
- •5. Patients with history of specific MRI findings (tumor, subdural haematoma, post-contusional changes, territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation, evidence of past macroscopic haemorrhage, or other relevant MRI findings that would interfere with evaluation)
- •6. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator`s discretion
- •7. 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
- •8. Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of screening, whichever is longer.
- •9. 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 (serum)
- •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. history or presence of severe myopia
- •a. in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters
- •b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma
- •c. in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
- •12. Acute optic neuritis within the past 6 months before screening
- •13. Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
- •14. Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
- •15. Concomitant use of drugs that may directly affect retinal structure and function (e.g.
- •chronic systemic corticosteroids [>30 consecutive days; doses higher than Cushing
- •threshold e.g. prednisone 7.5mg/d], intraocular anti-angiogenic drugs [ranibizumab, bevacizumab], intraocular steroids etc.)
- •* one month is defined as 28 days
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