Rheumatoid ArthritisPhase 3ALDORANCT05092984
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
A Phase 3 study testing Spironolactone in people with Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2022to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacques-Eric GOTTENBERG, Professor contact
France1 site, 1 recruiting
- Recruiting
University Hospital, Strasbourg, France
Strasbourg, Alsace, 67000
Jacques-Eric GOTTENBERG, MD, PhD
About this study
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)
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Spironolactone, Placebo
- Keywords
- rheumatoid arthritis, cardiovascular event, spironolactone, randomized controlled trial
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Spironolactone Mylan 25mg
77 patients will be treated with spironolactone Mylan 25mg/day for the first 3 months of the study. Dosage adjustment can be performed according to the eGFR (estimated Glomerular Filtration Rate) concentration at baseline and the serum potassium variation.
During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation.
PlaceboDrug
77 patients will be treated with placebo 25mg/day for the first 3 months. At inclusion, a second randomization is automatically performed in the placebo arm to determine patients receiving a dose adjustment during the study to keep the double-blind.
During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | Not described Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving DAS28-CRP < 3.2, comparison between spironolactone and placebo arms.
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.
Measured: at 3 months
Secondary outcomes (48)
Adverse events / Serious adverse events rate in each arm
Measured: 6 months
NT-proBNP level
Test for B-type natriuretic peptide (BNP), used for heart failure evaluation.
Measured: Day 0
NT-proBNP level
Test for B-type natriuretic peptide (BNP), used for heart failure evaluation.
Measured: 3 months
NT-proBNP level
Test for B-type natriuretic peptide (BNP), used for heart failure evaluation.
Measured: 6 months
Cardiac parameters: QRS duration (ms)
QRS duration (ms);
Measured: Day 0
Cardiac parameters: left ventricular end-diastolic volume index (mL/m2)
left ventricular end-diastolic volume index (mL/m2),
Measured: Day 0
Cardiac parameters: left ventricular ejection fraction (%)
left ventricular ejection fraction (%);
Measured: Day 0
Cardiac parameters: left ventricular mass index (g/m2)
left ventricular mass index (g/m2);
Measured: Day 0
Cardiac parameters: left atrial volume index (mL/m2)
left atrial volume index (mL/m2);
Measured: Day 0
Cardiac parameters: early mitral flow
early mitral flow;
Measured: Day 0
Cardiac parameters: velocity (E) (m/s)
velocity (E) (m/s);
Measured: Day 0
Cardiac parameters: late (atrial) mitral flow velocity (A) (m/s)
late (atrial) mitral flow velocity (A) (m/s);
Measured: Day 0
Cardiac parameters: E/A ratio
E/A ratio;
Measured: Day 0
Cardiac parameters: E/ early diastolic tissue velocity (e')
E/ early diastolic tissue velocity (e');
Measured: Day 0
Cardiac parameters: tricuspid annular plane systolic excursion
tricuspid annular plane systolic excursion
Measured: Day 0
Cardiac parameters: QRS duration (ms)
QRS duration (ms);
Measured: 3 months
Cardiac parameters: left ventricular end-diastolic volume index (mL/m2)
left ventricular end-diastolic volume index (mL/m2),
Measured: 3 months
Cardiac parameters: left ventricular ejection fraction (%)
left ventricular ejection fraction (%);
Measured: 3 months
Cardiac parameters: left ventricular mass index (g/m2)
left ventricular mass index (g/m2)
Measured: 3 months
Cardiac parameters: left atrial volume index (mL/m2)
left atrial volume index (mL/m2);
Measured: 3 months
Cardiac parameters: early mitral flow
early mitral flow;
Measured: 3 months
Cardiac parameters: velocity (E) (m/s)
velocity (E) (m/s);
Measured: 3 months
Cardiac parameters: late (atrial) mitral flow velocity (A) (m/s)
late (atrial) mitral flow velocity (A) (m/s);
Measured: 3 months
Cardiac parameters: E/A ratio
E/A ratio;
Measured: 3 months
Cardiac parameters: E/ early diastolic tissue velocity (e')
E/ early diastolic tissue velocity (e')
Measured: 3 months
Cardiac parameters: tricuspid annular plane systolic excursion
tricuspid annular plane systolic excursion
Measured: 3 months
CDAI score
Clinical Disease Activity Index for Rheumatoid Arthritis; 0-76; From 0.0 to 2.8: remission From 2.9 to 10.0: low activity From 10.1 to 22.0: moderate activity From 22.1 to 76.0: high activity
Measured: Day 0
CDAI score
Clinical Disease Activity Index for Rheumatoid Arthritis; 0-76; From 0.0 to 2.8: remission From 2.9 to 10.0: low activity From 10.1 to 22.0: moderate activity From 22.1 to 76.0: high activity
Measured: 3 months
CDAI score
Clinical Disease Activity Index for Rheumatoid Arthritis; 0-76; From 0.0 to 2.8: remission From 2.9 to 10.0: low activity From 10.1 to 22.0: moderate activity From 22.1 to 76.0: high activity
Measured: 6 months
Proportion of patients achieving DAS28-CRP < 3.2
Measured: 6 months
EULAR/ACR 20 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 3 months
EULAR/ACR 50 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 3 months
EULAR/ACR 70 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 3 months
Boolean remission score
Measured: 3 months
EULAR/ACR 20 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 6 months
EULAR/ACR 50 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 6 months
EULAR/ACR 70 2010 classification score
American College of Rheumatology 20/50/70 criteria
Measured: 6 months
Boolean remission score
Measured: 6 months
Concomitant treatment modification
Assess the change of concomitant treatments. In case of lack efficacy with clinical symptoms requiring the dosage modification of the current DMARD or the introduction of a new DMARD, the investigator is free to choose the best treatment for the patient. Nevertheless, DMARDs intensification due to worsening signs and symptoms of at any time of the trial will be considered as treatment failure.
Measured: 3 months
Concomitant treatment modification
Assess the change of concomitant treatments. In case of lack efficacy with clinical symptoms requiring the dosage modification of the current DMARD or the introduction of a new DMARD, the investigator is free to choose the best treatment for the patient. Nevertheless, DMARDs intensification due to worsening signs and symptoms of at any time of the trial will be considered as treatment failure.
Measured: 6 months
Treatment account (treatment boxes and patient diary)
Measured: 3 months
Treatment account (treatment boxes and patient diary)
Measured: 6 months
RAPID 3 (routine assessment of patient index data 3)
RAPID3 : Index to asses and monitor patients with RA
Measured: Day 0
RAPID 3 (routine assessment of patient index data 3)
RAPID3 : Index to asses and monitor patients with RA
Measured: 3 months
RAPID 3 (routine assessment of patient index data 3)
RAPID3 : Index to asses and monitor patients with RA
Measured: 6 months
HAQ scores
HAQ : Health Assessment Questionnaire
Measured: Day 0
HAQ scores
HAQ : Health Assessment Questionnaire
Measured: 3 months
HAQ scores
HAQ : Health Assessment Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start22 Jun 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques-Eric GOTTENBERG, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092984
- Sponsor's protocol ID
- 8154
- Other IDs
- 2021-003958-23
- Acronym
- ALDORA
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT05092984
- Acronym / sponsor ID
- ALDORA / 8154
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, cardiovascular event, spironolactone, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: Spironolactone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneAlso: Spironolactone Mylan 25mg77 patients will be treated with spironolactone Mylan 25mg/day for the first 3 months of the study. Dosage adjustment can be performed according to the eGFR (estimated Glomerular Filtration Rate) concentration at baseline and the serum potassium variation. During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation. | Drug | Spironolactone |
| Placebo77 patients will be treated with placebo 25mg/day for the first 3 months. At inclusion, a second randomization is automatically performed in the placebo arm to determine patients receiving a dose adjustment during the study to keep the double-blind. During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation. | Drug | Placebo |
Primary outcome
Proportion of patients achieving DAS28-CRP < 3.2, comparison between spironolactone and placebo arms.
Time frame: 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.
48 secondary outcomes
Adverse events / Serious adverse events rate in each arm
Time frame: 6 months
NT-proBNP level
Time frame: Day 0
NT-proBNP level
Time frame: 3 months
NT-proBNP level
Time frame: 6 months
Cardiac parameters: QRS duration (ms)
Time frame: Day 0
Cardiac parameters: left ventricular end-diastolic volume index (mL/m2)
Time frame: Day 0
Cardiac parameters: left ventricular ejection fraction (%)
Time frame: Day 0
Cardiac parameters: left ventricular mass index (g/m2)
Time frame: Day 0
Cardiac parameters: left atrial volume index (mL/m2)
Time frame: Day 0
Cardiac parameters: early mitral flow
Time frame: Day 0
Cardiac parameters: velocity (E) (m/s)
Time frame: Day 0
Cardiac parameters: late (atrial) mitral flow velocity (A) (m/s)
Time frame: Day 0
Cardiac parameters: E/A ratio
Time frame: Day 0
Cardiac parameters: E/ early diastolic tissue velocity (e')
Time frame: Day 0
Cardiac parameters: tricuspid annular plane systolic excursion
Time frame: Day 0
Cardiac parameters: QRS duration (ms)
Time frame: 3 months
Cardiac parameters: left ventricular end-diastolic volume index (mL/m2)
Time frame: 3 months
Cardiac parameters: left ventricular ejection fraction (%)
Time frame: 3 months
Cardiac parameters: left ventricular mass index (g/m2)
Time frame: 3 months
Cardiac parameters: left atrial volume index (mL/m2)
Time frame: 3 months
Cardiac parameters: early mitral flow
Time frame: 3 months
Cardiac parameters: velocity (E) (m/s)
Time frame: 3 months
Cardiac parameters: late (atrial) mitral flow velocity (A) (m/s)
Time frame: 3 months
Cardiac parameters: E/A ratio
Time frame: 3 months
Cardiac parameters: E/ early diastolic tissue velocity (e')
Time frame: 3 months
Cardiac parameters: tricuspid annular plane systolic excursion
Time frame: 3 months
CDAI score
Time frame: Day 0
CDAI score
Time frame: 3 months
CDAI score
Time frame: 6 months
Proportion of patients achieving DAS28-CRP < 3.2
Time frame: 6 months
EULAR/ACR 20 2010 classification score
Time frame: 3 months
EULAR/ACR 50 2010 classification score
Time frame: 3 months
EULAR/ACR 70 2010 classification score
Time frame: 3 months
Boolean remission score
Time frame: 3 months
EULAR/ACR 20 2010 classification score
Time frame: 6 months
EULAR/ACR 50 2010 classification score
Time frame: 6 months
EULAR/ACR 70 2010 classification score
Time frame: 6 months
Boolean remission score
Time frame: 6 months
Concomitant treatment modification
Time frame: 3 months
Concomitant treatment modification
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacques-Eric GOTTENBERG, Professor contact
Jacques-Eric GOTTENBERG, MD, PhD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spironolactone in people with Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques-Eric GOTTENBERG, Professor (3 88 12 79 53 ext. +33, jacques-eric.gottenberg@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving DAS28-CRP < 3.2, comparison between spironolactone and placebo arms. (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.