EUCTR2014-005527-27-IT进行中（未招募）1 期
A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT) - n.a
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
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 Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria, defined
- •in Section 5.4.1 of Study M14-197.
- •2. 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).
- •¿ Total abstinence from sexual intercourse as the preferred lifestyle of
- •the subject. Periodic abstinence is not acceptable.
- •¿ Practicing appropriate birth control, from the time of enrollment in this
- •study until at least 150 days after the last dose of study drug defined as
- •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 (IUD)
- •-Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly
- •-Hormonal contraceptives (note, low-dose progestin-only oral
- •contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are
- •not considered adequate)
- •-Double-barrier contraception* defined as: A male condom PLUSdiaphragm or cervical cap used with spermicidal jelly or cream.
- •* 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 or transdermal); (note, lowdose
- •progestin-only oral contraceptives such as norethindrone 0.35 mg
- •and lynestenol 0.5 mg are not considered adequate);
- •¿ Subject using condom and female partner(s) using double-barrier
- •method (contraceptive sponge; diaphragm or vaginal ring with
- •spermicidal jellies, creams, or spermicide);
- •¿ 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 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Pregnant or breastfeeding or plans to become pregnant during study
- •participation.
- •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 Study M14-197, which is required.
- •5. Consideration by the Investigator, for any reason, that the subject is
- •an unsuitable candidate to continue to receive ABT-122.
研究者
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