Study on Spironolactone for Treating Active Rheumatoid Arthritis in Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called spironolactone on a condition known as rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints, causing pain and swelling. The purpose of the study is to evaluate how effective spironolactone is in reducing the activity of rheumatoid arthritis over a period of three months, compared to a placebo.

Participants in the study will be randomly assigned to receive either spironolactone or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The medication will be taken orally in the form of a film-coated tablet. The study will last for a total of six months, with regular check-ups to monitor the participants’ health and the effects of the treatment.

Throughout the study, various health parameters will be assessed, including the level of rheumatoid arthritis activity and any potential side effects. The goal is to determine if spironolactone can help reduce the symptoms of rheumatoid arthritis and improve the quality of life for those affected by this condition. Participants will be closely monitored to ensure their safety and well-being during the trial.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of rheumatoid arthritis and ensuring that the condition is active, as indicated by a DAS28-CRP score of 3.2 or higher.

The assessment also checks for a stable response to existing treatments and corticosteroids, ensuring these have been consistent for at least 12 and 4 weeks, respectively.

2 randomization

Participants are randomly assigned to one of two groups: one receiving spironolactone and the other a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment.

3 medication administration

Participants in the spironolactone group receive a 25 mg dose of the medication in the form of a film-coated tablet. The medication is taken orally.

The treatment duration is set for 3 months, with the medication taken as prescribed by the study protocol.

4 monitoring and follow-up

Throughout the trial, participants undergo regular monitoring to assess the effectiveness of the treatment and to record any side effects. This includes measuring the DAS28-CRP score to evaluate changes in rheumatoid arthritis activity.

Additional assessments may include cardiac parameters and other health indicators to ensure participant safety.

5 completion of trial

At the end of the 3-month period, a final assessment is conducted to determine the proportion of participants achieving a DAS28-CRP score of less than 3.2.

Participants are informed of their results and any necessary follow-up actions are discussed.

Who Can Join the Study?

Patients must be 18 years of age or older.
Must have a diagnosis of rheumatoid arthritis (RA) according to specific medical guidelines.
Must have active rheumatoid arthritis, which means a certain level of disease activity measured by a score called DAS28-CRP that is 3.2 or higher.
Must have had an insufficient response to a stable treatment with disease-modifying antirheumatic drugs (DMARDs) for at least 12 weeks. DMARDs are medications used to slow down rheumatoid arthritis.
Must be on a stable dose of corticosteroids for at least 4 weeks before joining the study. Corticosteroids are medications that help reduce inflammation.
Must be able to understand the study’s goals and risks and provide a written informed consent to participate, which means agreeing in writing after understanding the study.
Must have been informed about the results of a preliminary medical visit.
If a woman can have children, she must not plan to become pregnant during the study and must agree to use effective birth control during the study and for 5 days after the last visit or last dose of treatment if the study ends early.
Must be affiliated with a social security system, meaning they have access to healthcare coverage.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with severe kidney problems are excluded. This means if your kidneys are not working well, you cannot join.
People with a history of severe heart conditions, like heart failure, are not allowed to participate.
If you have a known allergy to spironolactone or similar medications, you cannot take part in the study.
Participants who are currently using certain medications that might interfere with the study drug are excluded. This means if you are taking drugs that could affect how spironolactone works, you cannot join.
Individuals with uncontrolled high blood pressure, which means your blood pressure is not well-managed, cannot participate.
Patients with other serious medical conditions that might affect the study results are not allowed to join. This means if you have another illness that could change how the study works, you cannot be part of it.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country	Status
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hsmspzkd Uotmxgthnfmaqh Ssmrrfcyel &lpsgoe Hzmxyxe db Hgcsqkbmkie	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	22.06.2022
Germany	Not recruiting	22.06.2022

Trial locations

Investigated drugs:

Spironolactone

Spironolactone is a medication being tested in this trial for its effectiveness in treating active rheumatoid arthritis. Rheumatoid arthritis is a condition that causes pain and swelling in the joints. Spironolactone is traditionally used as a diuretic, which means it helps the body get rid of excess fluid. However, in this trial, researchers are investigating whether it can also help reduce the symptoms of rheumatoid arthritis, such as joint pain and inflammation.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body’s own tissues, leading to inflammation. Over time, this inflammation can cause joint damage, pain, and swelling. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. Additionally, rheumatoid arthritis can affect other parts of the body, including the skin, eyes, lungs, and blood vessels.

Trial ID:

2024-516884-10-00

Protocol code:

8154

NCT ID:

NCT05092984

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Spironolactone for Treating Active Rheumatoid Arthritis in Patients

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