NCT01103024撤回3 期
A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior, or Panuveitis Requiring Immunosuppression (INSURE Study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Novartis
- 试验地点
- 13
- 主要终点
- Rate of recurrence
研究概览
简要总结
The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed the entire treatment period of the 28-week core study
- •Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension study
排除标准
- •Inability or unwillingness to undergo repeated subcutaneous injections
- •Inability to comply with study or follow-up procedures
- •Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- •Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS
- •They are using simultaneously double barrier or two acceptable methods of contraception
- •They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing
- •They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing
- •Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
- •Partners have been sterilized by vasectomy or other reliable means
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Rate of recurrence
时间窗: baseline to 52 weeks
次要结局
- Change in immunosuppressive medication score from core study baseline(baseline to 52 weeks)
- Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks(baseline to 52 weeks)
- Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication(baseline to 52 weeks)
- Mean change in best corrected visual acuity from baseline(baseline to 52 weeks)
- Change from baseline in Quality of Life/Patient reported outcome assessments(baseline to 52 weeks)
研究者
研究点 (13)
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