EUCTR2016-003113-94-ES进行中（未招募）1 期
Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety with Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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 all doses of study drug and Week 24 visit of Study 1311.5.
- •2. Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study including 16 weeks after last dose of study drug is given.
- •Accepted methods of contraception are as follows:
- •? combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, transdermal) associated with inhibition of ovulation initiated at least 1 month prior to study participation
- •? progestogen-only hormonal birth control associated with inhibition of ovulation, initiated at least 1 month prior to study participation
- •? bilateral tubal occlusion/ligation
- •? intrauterine device (IUD)
- •? intrauterine hormone-releasing system (IUS).
- •? Subject must have only vasectomized sexual partner(s)
- •? True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable).
- •Women of childbearing potential are defined as having experienced menarche and are:
- •? not postmenopausal (12 months with no menses without an alternative medical cause) and are
- •? not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
- •3. Females of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 155
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including after the last dose of study drug is given.
- •2. Premature discontinuation of the treatment in Study 1311.5 for any reason.
- •3. Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5.
- •4. Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5
- •5. Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization, as assessed by the investigator
研究者
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