CTRI/2016/04/006852已完成3 期
A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Novartis Healthcare Pvt Ltd11 个研究点 分布在 1 个国家目标入组 990 人开始时间: 2016年4月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 990
- 试验地点
- 11
- 主要终点
- 1. American College of Rheumatology 20 (ACR20) response at Week 24
研究概览
简要总结
- Purpose of Trial :
The purpose of this study is to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 24, to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years will be based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs. 2. FPFV for India- 22.12.2015 3. Target sample Size for India : 160
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
- •â€¢Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
- •â€¢Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
- •â€¢Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs. •Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week
- •â€¢Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week
- •â€¢Subjects on MTX must be on folic acid supplementation at randomization.
- •â€¢Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
- •â€¢Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
- •â€¢Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization.
排除标准
- •â€¢Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process.
- •â€¢Subjects taking high potency opioid analgesics.
- •â€¢Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
- •â€¢Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
- •â€¢Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
- •â€¢Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
- •â€¢Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents •Other protocol-defined exclusion criteria do apply.
结局指标
主要结局
1. American College of Rheumatology 20 (ACR20) response at Week 24
时间窗: 1. Week 0-24
次要结局
- 1.American College of Rheumatology 50 (ACR50) response at Week 24(2.Van der Heijde modified total Sharp score at Week 24. The SvH method includes, in each hand and foot, evaluations of areas for erosions and areas for joint space narrowing)
研究者
研究点 (11)
Loading locations...
相似试验
招募中
3 期
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious InfectionsNeutropeniaNCT06056297X4 Pharmaceuticals176
已完成
3 期
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)Graft Versus Host DiseaseNCT00366145Mesoblast, Inc.260
终止
3 期
Phase 3 IGIV, 10% in Alzheimer´s DiseaseAlzheimer´s DiseaseNCT01524887Baxalta now part of Shire508
已完成
3 期
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopaParkinson DiseaseNCT00381472GlaxoSmithKline393
已完成
3 期
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic ArthritisPsoriatic ArthritisNCT02404350Novartis Pharmaceuticals997