EUCTR2012-004845-34-CZ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
- •=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. Following the approval of Amendment 2, only patients with active disease” as defined above will be enrolled in the study.
- •Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than 80 mg/day.
- •At screening, patients must be receiving oral prednisone (=15 mg and < 80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with Methotrexate (MTX) (= 25 mg/week) orally or intravenously or intra muscular or subcutaneous). Patients can be receiving one or several of the following therapies: Azathioprine (=2.5 mg/kg/day), Mycophenolate mofetil (=2g daily, orally), Cyclosporine (=4 mg/kg daily, orally), Tacrolimus (=4 mg daily, orally).
- •The doses may not have been increased for at least 4 weeks prior to the randomization visit.
- •At randomization, patients have been receiving oral prednisone (=15 mg and < 80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with methotrexate (MTX) (= 25 mg/week) orally or intravenously or intra muscular or subcutaneous).
- •Azathioprine, mycophenolate mofetil, cyclosporine and tacrolimus have to be permanently discontinued at least 48 hours prior to the first study treatment injection, or longer as per Investigator’s judgment. These IMTs are not permitted anytime during the treatment period.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
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