NCT00771043撤回4 期
Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
研究概览
简要总结
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RRMS.
- •Patients with unilateral AON consistent with Multiple Sclerosis (MS).
- •Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
- •Age 18-55 years.
- •Expanded Disability Status Scale (EDSS) 0 to 5.
- •Understand and sign informed consent.
排除标准
- •History or presence of progressive multifocal leukoencephalopathy (PML).
- •Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
- •Immune-compromised in the judgment of the Investigator.
- •History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
- •Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
- •Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.
- •Previous treatment with > 1 Disease Modifying Therapy (DMT).
- •Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.
- •Previous treatment with TYSABRI®
- •Women who are not postmenopausal, surgically sterile, or willing to practice contraception.
- •Women pregnant, breast feeding, or planning to become pregnant.
- •Involved with other study protocol simultaneously without prior approval.
- •Determined not suitable for study participation by Investigator and/or Sponsor.
研究组 & 干预措施
TYSABRI
Experimental
干预措施: TYSABRI and AVONEX (Drug)
AVONEX
Experimental
干预措施: TYSABRI and AVONEX (Drug)
结局指标
主要结局
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
时间窗: Between week 4 and weeks 36
次要结局
- Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.(Between week 4 and weeks 36)
研究者
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