EUCTR2011-001460-22-DE进行中（未招募）不适用
A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
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
- •Ability and willingness to give written informed consent and comply with the requirements of the study protocol
- •Diagnosis of SSc, as defined using ACR criteria
- •Disease duration of = 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
- •Age = 18 years
- •= 15 and = 40 mRSS units at the screening visit
- •Uninvolved skin at injection sites
- •Active disease
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Rheumatic autoimmune disease other than SSc, including but not limited to, RA, systemic lupus erythematosis, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren syndrome and eosinophilic myalgia syndrome
- •Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
- •History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •Evidence of moderately severe concomitant nervous system, renal, endocrine or GI disease, as determined by the Principal Investigator
- •Pulmonary disease with FVC = 50% of predicted or a DLCO (hemoglobin corrected) = 40% of predicted
研究者
相似试验
进行中（未招募）
1 期
A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.Systemic Sclerosis (SSc)MedDRA version: 17.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-001460-22-GBF. Hoffmann-La Roche Ltd.87
进行中（未招募）
1 期
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.EUCTR2007-004271-19-NLCorthera, Inc.
进行中（未招募）
1 期
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.Estudio de fase II/III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de relaxina en sujetos con insuficiencia cardíaca aguda - RELAX-AHFPatients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment. Pacientes hospitalizados con insuficiencia cardíaca aguda (ICA), presión arterial normal o elevada y disfunción renal leve o moderadaMedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failureEUCTR2007-004271-19-ESCorthera, Inc.
进行中（未招募）
1 期
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.MedDRA version: 14.1 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 10007541 - Cardiac disordersEUCTR2007-004271-19-GBCorthera, Inc.
进行中（未招募）
不适用
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.MedDRA version: 14.1Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersEUCTR2007-004271-19-DECorthera, Inc.1,160