EUCTR2017-005028-11-PL进行中（未招募）1 期
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-TermSafety and Efficacy of Baricitinib in Patients with Systemic LupusErythematosus (SLE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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
- •Patients are eligible to be included in the study only if they meet all of
- •the following criteria at
- •Type of Patient and Disease Characteristics
- •[1] Have completed the final treatment study visit of an originating
- •study, such as Study JAHZ or Study JAIA. Patient Characteristics
- •[2] Male or nonpregnant, nonbreastfeeding female patient
- •a. Patients of child-bearing potential who are abstinent (if this iscomplete abstinence, as their preferred and usual lifestyle) or in a samesex
- •relationship
- •(as part of their preferred and usual lifestyle) must agree to either
- •remain abstinent or stay in a same-sex relationship without sexual
- •relationships with the opposite sex.
- •b. Total abstinence is defined as refraining from intercourse during the
- •entirety of the study and for at least 1 week following the last dose of
- •investigational product. Periodic abstinence, such as calendar,
- •ovulation, symptothermal, post-ovulation methods, and withdrawal, are
- •not acceptable methods of contraception.
- •c. Otherwise, patients of childbearing potential together with their
- •partners must agree to use 2 effective methods of contraception, where
- •at least 1 form is highly effective, for the entirety of the study and for at
- •least 1 week following the last dose of investigational product.
- •d. The following contraception methods are considered acceptable (the
- •patient should choose 2, and 1 must be highly effective [defined as less
- •failure rate per year when used consistently and correctly]):
- •? Highly effective birth control methods:
- •? Combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation: oral, intravaginal,
- •or transdermal
- •? Progestogen-only containing hormonal contraception associated with
- •inhibition of ovulation: oral, intravaginal, or transdermal
- •? Intrauterine device (IUD)/intrauterine hormone-releasing system
- •? Vasectomized male (with appropriate post-vasectomy documentation
- •of the absence of sperm in the ejaculate).
- •? Effective birth control methods:
- •? Male or female condom with spermicide. It should be noted that the
- •use of male and female condoms as a double barrier method is not
- •considered acceptable due to the high failure rate when these methods
- •are combined.
- •? Diaphragm with spermicide
- •? Cervical sponge
- •? Cervical cap with spermicide
- •Note: When local guidelines concerning highly effective or effective
- •methods of birth control differ from the above, the local guidelines must
- •be followed.
- •Patients of non?child-bearing potential are not required to use birth
- •control and they are defined as:
- •? Women who are infertile due to surgical sterilization (hysterectomy,
- •bilateral oophorectomy, or tubal ligation)
- •? Post-menopausal – defined either as
- •? A woman at least 50 years of age with an intact uterus, not on
- •hormone therapy, who has had either
- 另有 12 项未显示
排除标准
- •[1] Have significant uncontrolled cerebro-cardiovascular (for example,
- •myocardial infarction, unstable angina, unstable arterial hypertension,
- •severe heart failure, or cerebrovascular accident), respiratory, hepatic,
- •renal, gastrointestinal, endocrine, hematologic, neuropsychiatric
- •disorders, or abnormal laboratory values that, in the opinion of the
- •investigator, pose an unacceptable risk to the patient if investigational
- •product continues to be administered.
- •[2] Have a known hypersensitivity to baricitinib or any component of
- •this investigational product.
- •[3] Had investigational product permanently discontinued at any time
- •during a previous baricitinib study.
- •[3] Had temporary investigational product interruption at the final study
- •visit of a previous baricitinib study and, in the opinion of the
- •investigator, this poses an unacceptable risk for the patient's
- •participation in the study.
- •[4] Have any other condition that, in the opinion of the investigator,
- •renders the patient unable to understand the nature, scope, and possible
- •consequences of the study or precludes the patient from following and
- •completing the protocol.
- •[5] Are currently enrolled in any other clinical study involving an
- •investigational product or any other type of medical research, judged not
- •to be scientifically or medically compatible with this study.
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