EUCTR2013-003530-33-NL进行中（未招募）1 期
Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 520
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 who have completed Study M13-550 or Study M13-537 with ABT-494 and has not developed any discontinuation criteria, defined in Section 5.4.1 of that study.
- •2. If the subject has evidence of new latent TB infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug.
- •3. If female, subject must meet one of the following criteria:
- •Postmenopausal (defined as no menses for at least 1 year).
- •Surgically sterile (bilateral oophorectomy or hysterectomy).
- •Practicing from the time of screening until at least 30 days after the last dose of study drug at least TWO of the following methods of birth control:
- •- Tubal ligation
- •- Partner vasectomy (at least 6 months earlier) (the vasectomized male partner should be the sole partner for that female subject)
- •- Intrauterine device
- •- A male condom with spermicidal jelly or cream
- •- Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly or cream
- •- Hormonal contraceptives (injected, oral, transdermal or implanted methods) must have been taking at least 2 months prior to dosing
- •4. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 30 days post last dose of study drug.
- •5. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
- •6. Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
- •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 390
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1. Pregnant or breastfeeding female.
- •2. 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.
- •3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
- •4. Laboratory values from the visit immediately prior to Baseline Visit meeting the following criteria:
- •? Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 3.0 × ULN
- •? Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m2
- •? Total white blood cell count (WBC) < 2,000/µL
- •? Absolute neutrophil count (ANC) < 1,000/µL
- •? Platelet count < 50,000/µL
- •? Absolute lymphocytes count < 500/µL
- •? Hemoglobin < 8 gm/dL
- •5. Enrollment in another interventional clinical study while participating in this study.
- •6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
研究者
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