EUCTR2013-004002-25-GB进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in autoinjectors, to demonstrate efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 3 years in subjects with active Psoriatic Arthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 417
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
- •- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASification crietria for Psoriatic ARthritis (CASPAR) criteria
- •- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- •- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis
- •- Inadequate control of symptoms with NSAID
- •Other protocol-definied inclusion criteria may apply
- •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 367
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- •- Subjects taking high potency opioid analgesics
- •- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- •- Ongoing use of prohibited psoriasis treatments/medications
- •- Subjects who have ever received biologic immunomodulating agents except for those targeting TNF-alpha.
- •- Previous treatment with any cell-depleting therapies
- •Other protocol-definied exclusion criteria may apply
研究者
相似试验
进行中（未招募）
不适用
A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)Subjects at high risk of converting to Multiple SclerosisMedDRA version: 9.0Level: PTClassification code 10028245EUCTR2006-002982-38-FIMerck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany480
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy in patients with breast cancer that spread to other tissues.HER2-negative metastatic breast cancer.MedDRA version: 18.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2011-005335-97-BGF. Hoffmann-La Roche Ltd480
进行中（未招募）
不适用
A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)EUCTR2006-002982-38-EEMerck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA480
进行中（未招募）
1 期
16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active psoriatic arthritis.Psoriatic ArthritisMedDRA version: 19.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2014-003849-10-CZovartis Pharma Services AG341
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Atezolizumab or Placebo in Combination with Neoadjuvant Doxorubicin + Cyclophosphamide Followed by Paclitaxel + Trastuzumab +Pertuzumab in Early HER2-Positive Breast CancerEarly Human epidermal growth factor receptor 2 (HER2)-positive breast cancerEUCTR2018-001881-40-ESF. Hoffmann-La Roche Ltd224