2024-516050-22-00招募中3 期
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc
Azienda Ospedaliero-Universitaria Policlinico Umberto I2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2024年8月12日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- To evaluate efficacy of HCQ add-on compared to placebo by assessing changes from baseline of American College of Rheumatology Combined Response Index for Systemic Sclerosis (CRISS)(Khanna D 2009) at week 52.
研究概览
简要总结
To evaluate the efficacy and safety of hydroxychloroquine compared to placebo, at the oral dose of 6 mg/kg daily (up to 400 mg/day), in the treatment of early systemic sclerosis (SSc) associated to SSc standard therapies (immunosuppressive and/or vasoactive).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Follow Up
- 盲法
- Double (Analyst, Carer, Investigator, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013).
- •Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws)
- •Age >= 18 years
- •Disease duration <= 5 years from the first non-Raynaud’s symptom
- •Stable SSc standard treatment within 4 weeks prior to Screening visit
- •Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug)
排除标准
- •Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines
- •Deficiency of glucose-6-phosphate dehydrogenase
- •Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1
- •Pregnant or breast feeding women
- •Other contraindicated clinical and / or laboratory conditions
- •Age < 18 years
- •Body weight < 45 kg
- •History of retynopathy and/or maculopathy
- •History of severe miopathy (other than SSc related)
- •Anticoagulant and/or antiplatelet therapy
- •History of periferic neuropathy
- •History of hypoglycemia
- •History of bradycardia (HR<50) or ventricular arrhythmias
结局指标
主要结局
To evaluate efficacy of HCQ add-on compared to placebo by assessing changes from baseline of American College of Rheumatology Combined Response Index for Systemic Sclerosis (CRISS)(Khanna D 2009) at week 52.
To evaluate efficacy of HCQ add-on compared to placebo by assessing changes from baseline of American College of Rheumatology Combined Response Index for Systemic Sclerosis (CRISS)(Khanna D 2009) at week 52.
次要结局
- econdary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of: 1. European Systemic Sclerosis Global Disease Activity Index (ESScGDAI) at week 52
- Secondary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of: Visual Analogue Scale (VAS) for pain at weeks 26 and 52
- Secondary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of:Morning stiffness (MS) duration (in minutes) at weeks 26 and 52
- Secondary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of:The FACIT fatigue Index at week 26 and 52
- Secondary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of:Raynaud Condition Score (RCS) scale at week 26 and 52
- Secondary efficacy endpoints: To evaluate efficacy of HCQ add-on by assessing change from baseline of:Naifold Capillaroscopy (NC) main parameters and CSURI (Capillaroscopic Skin Ulcer Risk Index) at week 52
研究者
Valeria Riccieri
Scientific
Azienda Ospedaliero-Universitaria Policlinico Umberto I
研究点 (2)
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