NL-OMON47604已完成3 期
A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •-Patients with relapsing multiple sclerosis are eligible. Patients should meet
- •the criteria of MS based on McDonald criteria 2010 and International Pediatric
- •Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of
- •2012 (5) and have:
- •- At least one relapse (or attack) in the 12 months preceding randomization or
- •- At least two relapses (or attack) in the 24 months preceding randomization
- •- Less than or equal to 17 years of age and 10 years or older of age at
- •randomization
- •- Signed informed consent/assent obtained from patient and patient*s legal
- •representative (parents or guardians) according to local regulations.
排除标准
- •- EDSS score greater than 5.5 at screening or randomization visits
- •- Relapse within 30 days prior to randomization
- •- Treated with glatiramer acetate, interferons, or dimethyl fumarate within 1
- •month prior to randomization
- •- Treated with fingolimod, or intravenous immunoglobulins within 3 months prior
- •to randomization
- •- Treated with natalizumab, other immunosuppressant or immunomodulatory agents
- •such as cyclophosphamide, azathioprine, cyclosporine, methotrexate,
- •mycophenolate, within 6 months prior to randomization
- •- Treated with cladribine or mitoxantrone within 2 years prior to randomization
- •- Treated with alemtuzumab at any time
- •- History of HIV infection
- •- Contraindication for MRI
- •- Pregnant or breast-feeding females or those who plan to become pregnant
- •during the study
- •- Female patients of child-bearing potential not using highly effective
- •contraceptive method (contraception in both female and male is required).
研究者
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