2024-516884-10-00招募中3 期
A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF SPIRONOLACTONE FOR THE TREATMENT OF ACTIVE RHEUMATOID ARTHRITIS (RA) - ALDORA
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 4
- 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
To assess the efficacy of spironolactone on rheumatoid arthritis activity at 3 months compared to placebo.
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
- •patients 18 years of age and over
- •diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria
- •active RA: DAS28-CRP ≥ 3.2
- •insufficient response despite a stable DMARD treatment (cDMARD/tsDMARD/bDMARD) ≥ 12 weeks
- •stable dose of corticosteroid 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, she should have no desire to procreate for the duration of her 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
- •affiliation to a social security regime
排除标准
- •severe or acute renal insufficiency, defined by eGFR < 30mL/min
- •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)
- •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))
结局指标
主要结局
Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms
Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms
次要结局
- Adverse events / Serious adverse events rate in each arm
- NT-proBNP level
- Cardiac parameters : QRS duration (ms); left ventricular end-diastolic volume index (mL/m2), left ventricular ejection fraction (%); left ventricular mass index (g/m2); left atrial volume index (mL/m2); early mitral flow; velocity (E) (m/s); late (atrial) mitral flow velocity (A) (m/s); E/A ratio; E/ early diastolic tissue velocity (e'); tricuspid annular plane systolic excursion
- CDAI score
- Proportion of patients achieving DAS28-CRP < 3,2 at 6 months
- EULAR/ACR 20, 50, 70 2010 classification score and Boolean remission score at 3 and 6 months
- Concomitant treatment modification
- Treatment account (treatment boxes and patient diary)
- RAPID 3 and HAQ scores
研究者
Jacques-Eric GOTTENBERG
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (4)
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