EUCTR2009-015007-97-IT进行中（未招募）1 期
Retinal Nerve Fiber Layer (RNFL) as measured by Optical Coherence Tomography (OCT) to Depict axonal loss in Early RRMS treated with difFEreNt dosage of subCutaneous IFN bEta 1a - DEFENCE
DR. ENRICO MONTANARI0 个研究点目标入组 144 人开始时间: 2009年10月1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
- 144
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
- •oRR-MS diagnosis according to the revised Mc Donald criteria
- •oRRMS diagnosis within 2 years
- •oPatients of both sexes, aged 18-50 years
- •oPatients DMDs treatment na?ve
- •oPatients valid informed consent to take part in the study.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •oPrimary or secondary progressive MS
- •oPatients with previous DMD treatment courses
- •oPatients receiving oral or parenteral steroid or ACTH courses within the 30 days preceding visit 1 (prior to enrolment)
- •oPatients unwilling to comply with study requirements
- •oContra-indications for IFN-β1a treatment as defined in the SmPC or hypersensitivity to any components of formulation
- •oSuffer of dementia (DSM IV criteria) with a SIDAM score <33
- •oSuffer of major medical or psychiatric illness
- •oPrevious history of NORB
- •oContra-indications for tropicamide: patients with a narrow angle between the iris and cornea; closed angle glaucoma; hypersensitivity to tropicamide or any excipients of the formulation
研究者
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