A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF SPIRONOLACTONE FOR THE TREATMENT OF ACTIVE RHEUMATOID ARTHRITIS (RA) - ALDORA

Conditions

RHEUMATOID ARTHRITIS

Brief summary

Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGMicrocrystalline cellulose

DRUGlactose monohydrate

DRUGmagnesium stearate

DRUGcolloidal anhydrous silica. Coating: similar color to the reference

DRUGtype Opadry HP II (assumption: Opadry white HP 85F18422)

DRUGSPIRONOLACTONE VIATRIS 25 mg

DRUGcomprimé pelliculé sécable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France, Germany

Outcome results

None listed