EUCTR2009-015636-15-HU进行中（未招募）不适用
An Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis
Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company0 个研究点目标入组 260 人开始时间: 2010年2月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •1. Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.
- •2. All women of childbearing potential (WOCBP) as determined during the previous study (data must be available as source documents for this study) must have a negative urine pregnancy test result at the baseline visit and throughout the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation).
- •- Women of nonchildbearing potential (WONCBP) as determined during the previous study do not require a urine pregnancy test.
- •3. WOCBP who have sexual intercourse with a non-surgically sterilized male partner must agree and commit to the use of the following highly effective and reliable forms of contraception: hormone contraception, double-barrier contraception (eg, condom with spermicide), or an intrauterine device for the duration of the study and for 8 weeks after the last dose of investigational product.
- •- To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before the baseline visit.
- •All men (unless surgically sterile, as defined above) and WOCBP who have sexual
- •intercourse must agree and commit to use a highly effective and reliable form of
- •contraception, as stated above, for the duration of the study and for 8 weeks after the last dose of investigational product.
- •4. Willingness and ability to participate in all aspects of the study, including SC administration of the investigational product (by study personnel), completion of subject assessments, attending scheduled clinic visits, and compliance with all protocol requirements as evidenced by written informed consent.
- •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 255
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Pregnant or nursing women.
- •2. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject’s response.
- •3. Other clinically important abnormalities on the baseline physical examination or vital sign measurements (performed at week 20 in the previous study) or, any unresolved clinically significant abnormalities on laboratory tests prior to the week 20 visit.
- •4. Received any prohibited treatment during the previous study.
研究者
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