NCT05092984招募中3 期
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年6月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving DAS28-CRP < 3.2, comparison between spironolactone and placebo arms.
研究概览
简要总结
Evaluation of spironolactone, a well-known cardiological treatment, in patients with rheumatoid arthritis (RA).
The hypothesis is that spironolactone, through its anti-inflammatory and anti-fibrosis actions, decreases RA's activity. The primary objective is to assess the efficacy of spironolactone on RA activity by evaluating the proportion of patients achieving DAS28-CRP < 3.2 at 3 months (comparison between spironolactone and placebo arms). CRP (C reactive protein)
详细描述
RA is associated with increased cardiovascular (CV) morbidity and death compared to the general population due to chronic systemic inflammation. However, some cardiological drugs are effective in reducing CV mortality for high-risk patients in the general population, without inflammatory rheumatism. Open-label trials suggested that spironolactone could be an effective RA treatment due to its anti-inflammatory and anti-fibrotic properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 years of age and over
- •diagnosis of RA according to EULAR/ACR 2010 classification criteria
- •active RA: DAS28-CRP ≥ 3.2
- •insufficient response despite a stable DMARD treatment (cDMARD/tsDMARD(targeted synthetic DMARD)/bDMARD) ≥ 12 weeks
- •stable dose of corticosteroids for at least 4 weeks prior to inclusion
- •patient able to understand the objectives and risks of the study and to provide a written informed consent to participate in the study, dated and signed before initiating any trial-related procedure
- •patient having been informed about the results of the preliminary medical visit
- •if woman of childbearing, they should have no desire to procreate for the duration of their participation in the study, agreeing to use an effective contraception method* during the study and until 5 days following the last visit or last dose of treatment in case of early stop; acceptable birth control methods:
- •progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •male or female condom with or without spermicide*
- •cap, diaphragm or sponge with spermicide*
- •a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable, but not highly effective, birth control methods
- •affiliation to a social security regime
排除标准
- •severe or acute renal insufficiency, defined by eGFR < 30 mL/min
- •hyperkalemia, with K+ > 5,1 mmol/L
- •end-stage liver failure, cirrhosis
- •hypersensitivity to the active ingredients or intolerance to any of the excipients including lactose
- •Addison's disease
- •patient currently being treated with spironolactone, or previous spironolactone treatment in the last 3 months
- •concomitant treatment with:
- •mitotane,
- •other potassium-sparing diuretics (alone or in combination) such as amiloride, potassium canrenoate, eplerenone, triamterene
- •other inflammatory arthritis except associated Sjögren's syndrome
- •pregnancy (women of childbearing potential : positive blood pregnancy test at the inclusion visit (V0))
- •breastfeeding
- •participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or still under the exclusion period
- •unwillingness or incapacity to adhere to study protocol (language barriers, cognitive disorders, etc.).
- •subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- •patient who cannot be followed for 6 months
- •patient over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision (vulnerable subjects)
研究组 & 干预措施
Spironolactone
Experimental
干预措施: Spironolactone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients achieving DAS28-CRP < 3.2, comparison between spironolactone and placebo arms.
时间窗: at 3 months
DMARDs intensification due to worsening signs and symptoms of RA at any time of the trial will be considered as treatment failure. Discontinuation of spironolactone or placebo for at least 1 month will be considered as treatment failure.
次要结局
- Adverse events / Serious adverse events rate in each arm(6 months)
- NT-proBNP level(6 months)
- Cardiac parameters: left ventricular mass index (g/m2)(3 months)
- Cardiac parameters: velocity (E) (m/s)(3 months)
- Proportion of patients achieving DAS28-CRP < 3.2(6 months)
- EULAR/ACR 20 2010 classification score(6 months)
- EULAR/ACR 50 2010 classification score(6 months)
- EULAR/ACR 70 2010 classification score(6 months)
- Boolean remission score(6 months)
- Concomitant treatment modification(6 months)
- Treatment account (treatment boxes and patient diary)(6 months)
- Cardiac parameters: QRS duration (ms)(3 months)
- RAPID 3 (routine assessment of patient index data 3)(6 months)
- HAQ scores(6 months)
- Cardiac parameters: left ventricular end-diastolic volume index (mL/m2)(3 months)
- Cardiac parameters: late (atrial) mitral flow velocity (A) (m/s)(3 months)
- Cardiac parameters: left ventricular ejection fraction (%)(3 months)
- Cardiac parameters: E/A ratio(3 months)
- CDAI score(6 months)
- Cardiac parameters: left atrial volume index (mL/m2)(3 months)
- Cardiac parameters: early mitral flow(3 months)
- Cardiac parameters: E/ early diastolic tissue velocity (e')(3 months)
- Cardiac parameters: tricuspid annular plane systolic excursion(3 months)
研究者
研究点 (1)
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