EUCTR2014-001471-31-RO进行中（未招募）1 期
Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
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 preceding RCT study with ABT-122 and have not developed any discontinuation criteria, defined in Section 5.4.1 of that study.
- •2. If female, subject must meet one of the following criteria:
- •Postmenopausal (defined as no menses for at least 1 year)
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- •Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days of last dose of study drug. Females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time. Acceptable methods of contraception are:
- •o Total abstinence from sexual intercourse;
- •o Vasectomized partner(s) (vasectomy performed greater than or equal to 6 months prior to
- •patient screening);
- •o Hormonal contraceptives (oral, parenteral or transdermal) (initiated at least 3 months prior to initial study drug administration), combined with a barrier method (male condom, female condom or diaphragm);
- •o Intrauterine device;
- •o Double-barrier method (condoms plus either diaphragm or cervical/vault cap, with spermicidal jellies or creams)
- •* Note: A female condom and a male condom should not be used together. Also, because the contraceptive sponge has a high failure rate, particularly in multiparous females, it should not be considered an acceptable alternative.
- •3. Male who agrees to follow one of the protocol-specified pregnancy avoidance measures below, including refraining from donating sperm, for up to 150 days post last dose of study drug:
- •Subject using condom and female partner(s) using an intrauterine device (IUD);
- •Subject using condom and female partner(s) using hormonal contraceptives (oral, vaginal, parenteral [under the skin] or transdermal [through the skin]);
- •Subject using condom and female partner(s) using barrier method (diaphragm or cervical vault/cap with spermicidal jellies or creams);
- •Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable.
- •4. 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.
- •5. 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 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1. Pregnant or breastfeeding female.
- •2. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
- •3. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
- •4. Current enrollment in another investigational study; with the exception of M12-963, which is required.
- •5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
研究者
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