A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X

Eli Lilly and Company0 个研究点目标入组 1,276 人开始时间: 2012年5月17日最近更新: 2015年1月19日

适应症

试验速览

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•Patients are eligible to be included in the study only if they meet all of the following criteria:
•- Have completed 52 weeks of treatment in Study BCDS or Study BCDT.
•- For female patients of childbearing potential, must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control or remain abstinent while on study drug, or
•- For female patients of non-childbearing potential, defined as:
•Women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
•Women =60 years of age
•Women =40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH =40 mIU/mL).
•- Have given written informed consent approved by Lilly or its designee and the Investigational Review Board/Ethical Review Board (IRB/ERB) governing the site.
•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 1148
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 128

•Patients will be excluded from the study if they meet any of the following criteria:
•- Presence of significant uncontrolled cerebrocardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values at baseline that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered.
•- Have any other condition that 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, in the opinion of the Investigator.
•- Are unwilling or unable to comply with study procedures.
•- Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
•- Are Lilly employees or representatives of a third party organization (TPO) involved in the study who require exclusion of their employees.

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