EUCTR2011-006021-23-BG进行中（未招募）1 期
A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
Astellas Pharma Global Development0 个研究点目标入组 650 人开始时间: 2012年12月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the Subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Male or female subject is at least 18 years of age at the time of Informed Consent.
- •3. Subject completed the week 12 visit in one of the Phase 2, ASP015K RA studies within the previous 14 days.
- •4. Female subject must be either:
- •? Of non child bearing potential:
- •o Post-menopausal (defined as at least 1 year without any menses) prior to
- •enrollment, or
- •o Documented surgically sterile or status post hysterectomy (at least 1 month prior to enrollment)
- •? Or, if of childbearing potential,
- •o Must have a negative urine pregnancy test at enrollment, and
- •o Must use two forms of birth control1 (at least one of which must be a barrier method) starting at enrollment and throughout the study period and for 60 days] after the final study drug administration.
- •5. Female subject must not be breastfeeding at Baseline/Day 1 or during the study period, and for 60 days after final study drug administration.
- •6. Female subject must not donate ova starting at Baseline/Day 1 and throughout the study period, and for 60 days after final study drug administration.
- •7. Male subject and their female spouse/partners who are of
- •childbearing potential must be using highly effective contraception
- •consisting of two forms of birth control (one of which must be a barrier method) starting at Baseline/Day 1 and continue throughout the study period and for 90 days after the final study drug administration.
- •8. Male subject must not donate sperm starting at Baseline/Day 1 and throughout the study period, and for at least 90 days after final study drug administration.
- •9. Subject must be willing and able to comply with the study
- •requirements.
- •10. Subject agrees not to participate in another interventional study while on treatment.
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 390
排除标准
- •1. Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety.
- •2. Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study.
- •3. Subject is scheduled to receive a prohibited medication.
- •4. Subject has a planned major surgery.
- •5. Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study.
- •6. Subject has any of the following laboratory values within the
- •preceding 14 days prior to Day 1 study dosing, confirmed on re-test:
- •? Hemoglobin < 8 g/dL
- •? White blood cell count < 2000/mm3
- •? Absolute neutrophil count (ANC) < 1000/mm3
- •? Absolute lymphocyte count (ALC) < 500/mm3
- •? Platelet count < 50,000/mm3
- •? ALT = 3 x upper limit of normal
- •? AST = 3 x upper limit of normal
- •? Total bilirubin = 2 x upper limit of normal
- •? CPK > 1.5x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps.
研究者
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.Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of boneMedDRA version: 18.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859EUCTR2011-006021-23-BEAstellas Pharma Global Development650
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.Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of boneMedDRA version: 18.1Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859EUCTR2011-006021-23-PLAstellas Pharma Global Development Inc. (APGD)650
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