Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

The ALDORA study is a big research project testing a medicine called spironolactone for people with active rheumatoid arthritis (RA). Researchers want to find out if spironolactone can help reduce the signs and symptoms of RA over three or six months. They are also looking to see if it has any effects on heart health, as RA can sometimes affect the heart. Participants will either receive the spironolactone medicine or a dummy pill (placebo – which looks the same but contains no active medicine). This is a 'blinded' study, meaning neither the patient nor their doctor will know which treatment they are getting, which helps make the results fair and accurate. The study is particularly interested in how many people show a good improvement in their RA symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Les Hopitaux Universitaires De Strasbourg

Enrolment target

153

Start

09 Sep 2024

RHEUMATOID ARTHRITIS

What is this study about?

This study, named ALDORA, is investigating a medicine called spironolactone, which is already used for other health conditions. Researchers want to see if it can be a helpful treatment for people living with active rheumatoid arthritis (RA). RA is a long-term condition that causes pain, swelling, and stiffness in the joints. Finding new and effective treatments is really important for improving the quality of life for people with RA.

To find out if spironolactone works, the study will compare it to a 'placebo', which is a tablet that looks exactly like the study medicine but doesn’t contain any active drug. This comparison helps researchers determine if any improvements seen are truly due to the spironolactone or if they might happen anyway. Neither you nor your study doctor will know whether you're receiving the active medicine or the placebo, which makes the results more reliable.

The main goal of this study is to see how many people taking spironolactone show a significant improvement in their RA symptoms compared to those taking the placebo. They'll also be looking closely at any side effects and how the medicine might affect heart health, as RA can sometimes have an impact on the heart. This is a large, advanced-stage study, meaning it’s designed to confirm whether the treatment is effective and safe.

Key takeaways

The ALDORA study is testing if spironolactone can treat rheumatoid arthritis (RA).
It compares spironolactone to a dummy pill (placebo) to see if it helps reduce RA symptoms.
The study will also check for any effects on heart health and monitor for side effects.
Participants will have regular clinic visits, blood tests, and heart checks.
You won't know if you're taking the active medicine or the placebo.
This is a large, advanced-stage study aiming to confirm if spironolactone is effective and safe for RA.

Who may be eligible?

To take part in this study, you need to be an adult aged 18 or older. There is no upper age limit, meaning older adults can also participate. The study is open to both men and women.

The most important requirement is that you must have active rheumatoid arthritis. This means your RA symptoms are currently affecting you and might not be fully controlled by your current treatments. The study doctors will carefully check your medical records and do some tests to make sure you meet all the specific health criteria for the study.

There will also be other medical checks and criteria that are not listed here, to make sure the study medicine is safe for you. For example, conditions like severe kidney problems or certain heart issues might mean you can't join. Your study doctor or nurse will discuss all these with you in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have active rheumatoid arthritis?
Are you able to attend regular clinic appointments?
Are you willing to take a study medicine or placebo daily and keep a diary?
Are you happy for doctors to check your heart health and take blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to join the ALDORA study, you will be given either the study medicine (spironolactone) or a dummy pill (placebo) to take. You won't know which one you're getting, and neither will your doctor, which is standard for this type of research. You will take this medicine every day for a specific period, likely three or six months.

Throughout the study, you will have regular visits to the clinic. These visits will involve various checks and assessments. This includes physical examinations, giving blood samples to check your health and how the medicine is working, and filling out questionnaires about your symptoms and how you feel. Doctors will specifically measure your RA activity, such as using scores like DAS28-CRP and CDAI, and also check your heart health using different methods, including blood tests and possibly scans.

You will also be asked to keep a study diary to record any changes in your health or any side effects you notice. The total duration of your active participation in the study will likely be around six months, followed by some follow-up checks. All visits, tests, and medicines related to the study will be provided at no cost to you.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving a new treatment that might help your rheumatoid arthritis symptoms. You will also receive very close medical monitoring throughout the study, which can be reassuring. However, like all medicines, spironolactone may have side effects, and since you might receive a placebo, there's a chance you may not benefit from the active drug. Some common side effects of spironolactone can include feeling sick, dizziness, or changes in blood salt levels, which will be monitored closely. There might also be other unknown risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
France

Common questions

What is rheumatoid arthritis (RA)?

RA is a long-term condition where your body's immune system mistakenly attacks your own joints, causing pain, swelling, and stiffness.

What is spironolactone?

Spironolactone is a medicine already used for other conditions, such as high blood pressure and heart problems. This study is testing if it can also help with RA.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers know if the real medicine is actually working.

What does 'double-blind' mean?

Double-blind means that neither you, the patient, nor your study doctor will know if you are receiving the real medicine or the placebo. This helps keep the study fair.

How long will I be in the study?

The active part of the study where you take the medicine and have regular checks will likely last about six months.