Evaluation of Two Prednisolone Treatment Strategies for Newly Diagnosed, Untreated Rheumatoid Arthritis Patients

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What is this study about?

This clinical trial is focused on studying the treatment of rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will use a medication called Prednisolone, which is a type of steroid that helps reduce inflammation and pain. Two different doses of Prednisolone will be used: 5 mg and 2.5 mg tablets, both taken orally. The purpose of the study is to evaluate two strategies for reducing the dosage of Prednisolone in patients who have recently been diagnosed with rheumatoid arthritis and have not been treated before.

Participants in the study will be randomly assigned to one of two groups. One group will follow a faster reduction of the low-dose Prednisolone, while the other group will follow a slower reduction of the same starting dose. The study will last for a period of up to 51 weeks, during which the effects of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment strategies.

The study aims to determine if the faster reduction of Prednisolone is not worse than the slower reduction in managing the symptoms of rheumatoid arthritis. Throughout the study, the health and progress of the participants will be closely observed to ensure their safety and to gather information on the effectiveness of the treatment. The results will help in understanding the best approach to using Prednisolone for newly diagnosed patients with rheumatoid arthritis.

1 joining the study

Upon joining the study, you will be asked to provide a signed consent form. This confirms your agreement to participate and that you understand the study’s purpose and procedures.

2 initial assessment

An initial assessment will be conducted to confirm your diagnosis of rheumatoid arthritis according to the 2010 classification criteria. This assessment ensures that you meet the study’s inclusion criteria.

3 medication administration

You will be randomly assigned to one of two treatment strategies involving the medication prednisolone. This medication is taken orally in the form of tablets.

The dosage and frequency of prednisolone will depend on the specific treatment strategy you are assigned to. The study aims to compare a rapid reduction in dosage with a slower reduction, both starting from the same initial dose.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your progress. These visits will include assessments of your clinical effectiveness, which is measured by the time-averaged DAS28 score at month 12.

Additional assessments will be conducted at months 6, 12, and 24 to evaluate improvements in pain, function, quality of life, fatigue, and general health.

5 safety monitoring

Throughout the study, your safety will be closely monitored. This includes tracking any adverse events (AEs) or serious adverse events (SAEs) that may occur during the 2-year duration of the study.

6 treatment evaluation

At months 12 and 24, the need for any additional treatment, such as the addition of a biological disease-modifying antirheumatic drug (bDMARD), will be evaluated based on the effectiveness of the initial treatment strategy.

7 study completion

The study is expected to conclude by December 31, 2025. Upon completion, the results will be analyzed to determine the effectiveness of the two treatment strategies.

Who Can Join the Study?

Signed consent form: You must agree to participate in the study by signing a consent form.
Diagnosis of Rheumatoid Arthritis (RA): You must have been diagnosed with rheumatoid arthritis according to the 2010 classification criteria.
Age 18 years or older: You must be at least 18 years old to participate.
Treatment-naive RA patients: You should not have received any prior treatment for rheumatoid arthritis.
Eligible for prednisolone treatment: You must be suitable for treatment with prednisolone, a type of medication, according to treatment guidelines, and have no reasons that would prevent you from taking this medication in the doses used for this study.

Who Cannot Join the Study?

Patients with any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse.
Patients who have been diagnosed with a mental health condition that could interfere with the study.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are taking medications that could interfere with the study medication.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.06.2021

Trial locations

Investigated drugs:

Prednisolone

Prednisolone is a type of medication known as a corticosteroid, which is often used to reduce inflammation in the body. In this clinical trial, Prednisolone is being tested to see how effective it is in treating newly diagnosed rheumatoid arthritis. The study is comparing two different strategies for reducing the dose of Prednisolone over time. The goal is to find out if a faster reduction in the dose is just as effective as a slower reduction for patients with this condition. Prednisolone helps to manage symptoms like pain and swelling by calming down the immune system’s response. This can help improve the quality of life for people with rheumatoid arthritis by making it easier for them to move and perform daily activities.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation in the synovial membrane, leading to swelling, pain, and stiffness, especially in the morning or after periods of inactivity. Over time, the inflammation can cause damage to the cartilage and bone within the joint, resulting in joint deformity and loss of function. The disease often progresses symmetrically, meaning it affects the same joints on both sides of the body. In addition to joint issues, rheumatoid arthritis can also affect other systems in the body, causing symptoms such as fatigue and general malaise. The progression of the disease can vary greatly among individuals, with periods of increased activity (flares) and periods of remission.

Trial ID:

2024-518775-54-00

Protocol code:

OPRERA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluation of Two Prednisolone Treatment Strategies for Newly Diagnosed, Untreated Rheumatoid Arthritis Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?