Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Steroid Withdrawal in Systemic Lupus Erythematosus Patients Using Prednisone

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

6 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Prednisone – Prednisone is typically administered orally in the form of tablets. It is a well-established medication in medical literature, commonly used for its anti-inflammatory and immunosuppressive properties. The main therapeutic indication for prednisone is the treatment of conditions like Systemic Lupus Erythematosus (SLE), where it helps reduce inflammation and suppress the immune system. At the molecular level, prednisone works by mimicking the effects of cortisol, a natural hormone, thereby reducing the activity of the immune system. It is classified as a corticosteroid.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518580-35-00Protocol codeTARGET2020Estimated enrolment252 patientsSponsorAzienda Ospedaliero Universitaria Pisana

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).