EUCTR2012-003881-42-RO进行中（未招募）不适用
A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Main Inclusion:
- •1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study
- •2. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
- •Hormonal contraceptives for 90 days prior to study drug administration;
- •A vasectomized partner;
- •3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections
- •4. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline
- •5. Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated
- •2. Subject currently uses or plans to use anti-retroviral therapy at any time during the study
- •3. Subject plans to use any live vaccine during the study
- •4. Positive pregnancy test at Baseline (Week 0)
- •5. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究者
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