Study on Steroid Withdrawal in Systemic Lupus Erythematosus Patients Using Prednisone

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What is this study about?

This clinical trial is focused on studying Systemic Lupus Erythematosus (SLE), a disease where the immune system mistakenly attacks healthy tissues in the body. The study is examining the effects of withdrawing a medication called Prednisone, which is a type of drug known as a glucocorticoid. Glucocorticoids are often used to reduce inflammation and suppress the immune system. In this trial, participants will either stop taking Prednisone or continue with a low dose to see if stopping the medication is just as effective as continuing it for maintaining a stable condition.

The purpose of the study is to determine if patients with SLE, who are already on standard treatment and have their disease under control, can safely stop taking glucocorticoids without worsening their condition. Participants will be monitored over a period of 36 months to see if they can maintain a stable state without the medication. The study will involve regular check-ups to ensure the health and safety of the participants.

Throughout the study, the main focus will be on whether patients can maintain a stable condition known as low disease activity state (LLDAS) after stopping glucocorticoids. The trial will also look at how many patients remain in remission, meaning their disease is not active, at different points during the study. This research aims to provide valuable information on the long-term management of SLE and the potential benefits of reducing medication use.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be between 18 and 75 years old and diagnosed with systemic lupus erythematosus (SLE) according to established criteria.

Participants must have stable treatment for SLE, including immunosuppressive drugs and antimalarials, for at least six months prior to the study.

2 initial assessment

An initial assessment is conducted to ensure participants meet the criteria for low disease activity. This includes a stable treatment with prednisone at a dosage of 5 mg per day or less for a minimum of six months.

Participants must also demonstrate adherence to hydroxychloroquine (HCQ) with blood levels of 500 ng/mL or higher.

3 randomization

Participants are randomly assigned to either continue their current low-dose glucocorticoid treatment or to begin a withdrawal process from glucocorticoids.

The objective is to determine if glucocorticoid withdrawal is as effective as maintaining a low dose in keeping the disease under control.

4 treatment phase

Participants follow their assigned treatment plan for a period of 36 months. Those in the withdrawal group gradually reduce their glucocorticoid dosage under medical supervision.

Regular monitoring is conducted to assess disease activity and ensure safety throughout the treatment phase.

5 follow-up assessments

Participants undergo follow-up assessments at 12, 24, and 36 months to evaluate the maintenance of low disease activity.

The primary goal is to measure the proportion of participants maintaining low disease activity throughout the study period.

6 study completion

Upon completion of the 36-month period, final assessments are conducted to gather data on the long-term effects of glucocorticoid withdrawal versus maintenance.

The study aims to provide insights into the management of SLE with reduced reliance on glucocorticoids.

Who Can Join the Study?

Must be between 18 and 75 years old.
Must have been diagnosed with Systemic Lupus Erythematosus (SLE) according to specific criteria set in 2019.
Must have had stable treatment for SLE with medications that suppress the immune system for at least 4 months.
Must have been in a stable condition called modified LLDAS for at least 6 months before the screening visit. This means:
- A score of 4 or less on a specific disease activity index called SLEDAI-2K, with no active disease in major organs like kidneys, brain, heart, lungs, blood vessels, and no fever or specific types of anemia.
- No new signs of lupus activity compared to the last check-up.
- A physician’s global assessment score of 1 or less on a scale from 0 to 3.
- Well-tolerated standard doses of medications that suppress the immune system and approved biologic drugs.
- Stable treatment with a low dose of prednisone (or similar medication) of 5 mg per day or less for at least 6 months.
Must have been on stable treatment with antimalarial drugs for SLE for at least 6 months, unless they cannot take them or do not tolerate them well.
Must have shown they are taking hydroxychloroquine (HCQ) as prescribed, with blood levels of 500 ng/mL or more at screening.
Must have signed a form agreeing to participate in the study, known as informed consent.

Who Cannot Join the Study?

Patients who do not have Systemic Lupus Erythematosus (SLE) cannot participate. SLE is a condition where the immune system attacks the body’s own tissues.
Patients who are not in LLDAS cannot participate. LLDAS stands for “Lupus Low Disease Activity State,” which means the disease is not very active.
Patients who are not on standard-of-care (SoC) therapy cannot participate. SoC therapy refers to the usual treatment given for a condition.
Patients who are not between the ages of 18 and 65 cannot participate.
Both male and female patients can participate, but those who do not identify as either cannot participate.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Di Pisa	Pisa	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	05.03.2024

Trial locations

Investigated drugs:

Prednisone

Glucocorticoids (GC) are medications used to reduce inflammation and suppress the immune system. In this trial, they are being tested to see if stopping them is as effective as continuing a low dose in patients with Systemic Lupus Erythematosus (SLE) who are already on standard treatment and have stable disease.

Investigated diseases:

Systemic lupus erythematosus

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissues. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever, which can vary in severity and may come and go. The disease progresses with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to damage in the affected organs and tissues. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.

Trial ID:

2024-518580-35-00

Protocol code:

TARGET2020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Steroid Withdrawal in Systemic Lupus Erythematosus Patients Using Prednisone

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