EUCTR2011-005249-12-PT进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- •-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
- •screening or
- •- at least two relapses (or attack) in the 24 months preceding
- •-=18 years of age and =10 years of age at randomization. Specific for
- •the Russian Federation from 18 December 2014 to 26 July 2016, =17
- •years of age and =13 years of age at randomization
- •-Signed informed consent/assent obtained from patient and patient's
- •legal representative (parents or guardians) according to local
- •regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 165
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •EDSS score > 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
- •- fingolimod, or intravenous immunoglobulins within 3 months prior to
- •randomization
- •- natalizumab, other immunosuppressant or immunomodulatory agents
- •such as cyclophosphamide, azathioprine, cyclosporine, methotrexate,
- •mycophenolate, within 6 months prior to randomization
- •- 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
研究者
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