EUCTR2017-005028-11-NL进行中（未招募）1 期
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
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 is complete abstinence, as their preferred and usual lifestyle) or in a same-sex 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 than 1%
- •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, injectable, or implantable
- •? Intrauterine device (IUD)/intrauterine hormone-releasing system (IUS)
- •? 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
- •? Cessation of menses for at least 1 year
- •? At least 6 months of spontaneous amenorrhea with follicle- stimulating hormone >40 mIU/mL
- •? Women aged 55 years or older who are not on hormone therapy, and who have had at least 6 months of spontaneous amenorrhea
- •? Women aged 55 years or older who have a diagnosis of menopause
- •Informed Consent
- •[3] Must read and understand the informed consent approved by Eli Lilly and
- •Company (Lilly), or its designee, and the institutional review board (IRB)/ethics
- •review board (ERB) governing the site, and provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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.
研究者
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