EUCTR2012-004845-34-ES进行中（未招募）1 期
A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients with Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU) - SARILNIUSATUR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •sup or equal 18 years of age.
- •Non-infectious intermediate-, posterior-, or pan-uveitis in the study eye.
- •Active disease at screening or evidence of activity within the 3 months prior to screening visit.
- •On stable dose of prednisone or equivalent steroid compound for at least 4 weeks prior to randomization.
- •Signed written informed consent.
- •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 62
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Patient with best-corrected visual acuity worse than 20 ETDRS letters in at least one eye.
- •Patient with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic etiology.
- •Patient with primary diagnosis of anterior uveitis.
- •Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab and sarilumab.
研究者
相似试验
进行中（未招募）
1 期
Phase II Study to Analyze Sarilumab in Non-Infectious UveitisveitisMedDRA version: 17.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersEUCTR2012-004845-34-DESanofi-aventis recherche et développement70
进行中（未招募）
1 期
Phase II Study to Analyze Sarilumab in Non-Infectious UveitisveitisMedDRA version: 16.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersEUCTR2012-004845-34-ITSanofi-aventis recherche et développement70
进行中（未招募）
1 期
Phase II Study to Analyze Sarilumab in Non-Infectious UveitisveitisMedDRA version: 17.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersEUCTR2012-004845-34-CZSanofi-aventis recherche et développement70
进行中（未招募）
不适用
/APatients with Diabetic Kidney Disease due to Type 1 or Type 2 DiabetesMedDRA version: 15.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-020404-29-CZEli Lilly and Company Limited, Indianapolis400
进行中（未招募）
不适用
A study in Patients with Diabetic Kidney DiseasePatients with Diabetic Kidney Disease due to Type 1 or Type 2 DiabetesMedDRA version: 15.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-020404-29-HUEli Lilly and Company Limited, Indianapolis400