CTRI/2011/09/002026已完成3 期
A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Novartis Healthcare Pvt Ltd13 个研究点 分布在 1 个国家目标入组 1,264 人开始时间: 2011年9月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,264
- 试验地点
- 13
- 主要终点
- •Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI (psoriasis area and severity index) and IGA (investigators global assessment)
研究概览
简要总结
Purpose of the study:
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
FPFV for India:30- Sep-2011
Enrolment target for India:120
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Behçets disease and with a history of recurrent uveitis in a least one eye.
- •Documented evidence of Greater than22 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening).
- •Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation: Greater than 2 plus vitreous haze with less than 2plus anterior chamber cell grade (intermediate or posterior uveitis) or Greater than22 plus vitreous haze with Greater than22 plus anterior chamber cell grade (panuveitis) presence of retinal infiltrates or vasculitis or hemorrhages documented Greater than210 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçets disease.
- ••Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçets disease: Prednisone or equivalent Greater than210 mg daily The need for at least Greater than21 periocular injection or Greater than21 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening) Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids.
- •(Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.) Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.
排除标准
- •Subjects with infectious uveitis, uveitis due to other causes than Behçets disease, or uveitis of unknown etiology.
- •Less severe (i.e. anterior) uveitis associated with Behçets disease.
- •Ocular treatments Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
- •Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
- •Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle Systemic conditions or treatments Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
- •Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN
- •Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).
结局指标
主要结局
•Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI (psoriasis area and severity index) and IGA (investigators global assessment)
时间窗: Time Frame: 12 wks
次要结局
- 1.To determine if AIN457 can reduce the need for standard-of-care immuno(suppressivemedications(ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçets disease as measured by the ISM score)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
2 期
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisGiant Cell ArteritisNCT03765788Novartis Pharmaceuticals52
已完成
3 期
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 YearModerate to Severe Plaque-type PsoriasisNCT01365455Novartis Pharmaceuticals738
已完成
3 期
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritisSpondyloarthritisNCT03136861Novartis Pharmaceuticals383
已完成
3 期
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type PsoriasisChronic Plaque PsoriasisNCT01358578Novartis Pharmaceuticals1,306
已完成
3 期
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp PsoriasisChronic Scalp PsoriasisNCT02267135Novartis Pharmaceuticals102