EUCTR2012-001171-37-Outside-EU/EEA进行中（未招募）不适用
A Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 913200 个研究点目标入组 594 人开始时间: 2012年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 594
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
- •Boys or girsl agew 2 to 18 years (inclusive) with a diagnosis of systemic, polyarticular, or pauciarticular JRA defined by the American College of Rheumatology (ACR) criteria.
- •Duration of disease long enough for the subject to have been given an adequate trial of nonsteroidal anti-inflammatory drug (NSAID) and/or prednisolone.
- •Co-administration of other DMARDS that did not specifically inhibit TNF (eg: infliximab, thalidomide, D2E7 [adalimumab]).
- •Parent or legal guardian able and willing to give informed consent.
- •Disease course must have been polyarticular or systemic with active arthritis in greater than or equal to 3 joints at the time of starting methotrexate alone or methotrexate in combination with other DMARDS, etanercept alone or etanercept added to ongoing methotrexate or other DMARDS.
- •Pre-pubescent, or if post-pubertal at any time during the study and of childbearing potential must practice adequate contraception
- •Etanercept Arm
- •Newly started etanercept or began etanercept within 6 months of enrollment into the study. Subjects who entered the study from selected Immunex protocols and may have received etanercept for up to 1 year had their time of exposure counted from the first dose of etanercept in the original Immunex study.
- •Methotrexate Arm
- •Newly started methotrexate or began methotrexate within 6 months of enrollment into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 583
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or nursing
- •Receipt of antibody to TNF (infliximab, adalimumab, or other anti-TNF), antibody to CD4 (anti CD4), or diphtheria interlukin-2 fusion protein (DAB-IL-2).
- •Participation in a study of an investigational drug or biologic other than etanercept that required informed consent = 6 months.
- •Receipt of any of the following DMARDS: TNF inhibitors other than etanercept such as infliximab, thalidomide, adalimumab, cyclophosphamide, experimental agents; or other biologic agents
- •Any serious concurrent medical condition, either acute or chronic, which would compromise the subject’s ability to cooperate with the protocol requirements.
- •History of alcohol or drug abuse
- •Prior malignancies unless the subject had been disease-free for at least 5 years.
- •Serious concurrent medical conditions, either acute or chronic (including infections) that prevent the subject from receiving a TNF inhibitor.
研究者
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