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Study on Stopping Prednisone for Patients with Inflammatory or Autoimmune Disorders

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What is this trial about?

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

This clinical trial is focused on studying the effects of stopping or gradually reducing the use of glucocorticoids, a type of steroid medication, in patients with inflammatory or autoimmune disorders. These disorders occur when the body's immune system mistakenly attacks its own tissues, causing inflammation and other symptoms. The medication being studied is Prednisone, which is commonly used to reduce inflammation and suppress the immune system. The trial will compare two approaches: stopping the medication immediately or gradually reducing the dose over four weeks.

The purpose of the study is to determine if stopping glucocorticoid treatment quickly is as safe and effective as slowly reducing the dose. Participants will be randomly assigned to one of the two groups. Some participants will receive a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of up to 28 days, during which participants will be monitored for any health changes, including the need for additional treatment or any serious health events.

Throughout the study, participants' overall health and any symptoms they experience will be closely observed. This includes monitoring for signs of adrenal insufficiency, a condition where the body does not produce enough of certain hormones after stopping steroid treatment. The study aims to provide valuable information on the best way to discontinue glucocorticoid therapy in patients with inflammatory conditions, ensuring their safety and well-being.

The research process

The trial runs in 5 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 such as age, previous glucocorticoid dosage, and duration of therapy.

    Informed consent is required, which involves understanding the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate health status and establish a baseline for the study.

    This may include a review of medical history and current health conditions related to inflammatory or autoimmune disorders.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to one of two groups: immediate termination of glucocorticoid treatment or a tapering regime over four weeks.

    The medication used is prednisone, administered orally. The dosage is determined based on previous treatment, with a minimum of 7.5 mg per day.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track health outcomes, including any occurrences of hospitalization, adrenal crisis, or need for additional glucocorticoid therapy.

    Participants self-assess their general health status using a visual analog scale from 0 to 100.

  5. Step 5

    Final assessment

    A final assessment is performed to evaluate the overall health status and any changes since the beginning of the study.

    The study aims to determine if rapid termination of glucocorticoid treatment results in similar outcomes compared to a tapering regime.

Who can join the trial?

7 criteria

  • Provide a signed document showing you understand and agree to participate in the study, known as Informed Consent.
  • Be at least 18 years old.
  • Currently taking a daily dose of at least 7.5 mg of a medication called glucocorticoid, which is similar to a drug called prednisone.
  • Have been on this medication for at least 28 days.
  • Have been taking an average daily dose of at least 7.5 mg of glucocorticoid until now.
  • Have taken a total amount of at least 420 mg of glucocorticoid before joining the study.
  • Not required to gradually reduce the medication to treat your condition anymore.

Who cannot join the trial?

4 criteria

  • Patients with **inflammatory or autoimmune disorders** cannot participate. These are conditions where the body's immune system attacks its own tissues, causing inflammation and damage.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Both **male and female** patients are eligible, but if a patient does not fit the gender criteria, they cannot participate.
  • Patients who are considered part of a **vulnerable population** cannot participate. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Glucocorticoids are medications used to reduce inflammation in the body. They are often prescribed for various inflammatory disorders. In this trial, the focus is on comparing two methods of stopping glucocorticoid treatment: stopping immediately or gradually reducing the dose over four weeks. The goal is to see if stopping quickly is as safe and effective as tapering off the medication.

What is already known about the treatment

Glucocorticoids – These medications are typically administered orally or through injection and are used to treat inflammatory or autoimmune disorders. They are well-established in medical practice and literature, often prescribed to reduce inflammation and suppress the immune system. The main therapeutic indications include conditions like arthritis, asthma, and lupus. At the molecular level, glucocorticoids work by binding to glucocorticoid receptors, which then influence the expression of specific genes that control inflammation and immune responses. They belong to the pharmacological class of corticosteroids.

Investigated diseases

  • 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 tissues, causing joint pain, swelling, and stiffness. Over time, it can lead to joint damage and deformities. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees and hips. Symptoms may vary in severity and can come and go, with periods of increased disease activity known as flares.

  • Systemic Lupus Erythematosus

    Systemic lupus erythematosus is an autoimmune disease where the immune system attacks its own tissues, causing widespread inflammation and tissue damage. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, rash, and fever, and they can vary widely among individuals. The disease is characterized by periods of illness, called flares, and periods of remission when symptoms improve. The exact cause is unknown, but it is believed to involve genetic, environmental, and hormonal factors.

  • Psoriasis

    Psoriasis is a chronic autoimmune condition that causes the rapid growth of skin cells, leading to scaling on the skin’s surface. The extra skin cells form scales and red patches that can be itchy and sometimes painful. It typically affects the skin on the elbows, knees, scalp, and lower back, but it can appear anywhere on the body. The condition tends to go through cycles, flaring for a few weeks or months, then subsiding or going into remission. Factors such as stress, infections, and cold weather can trigger or worsen symptoms.

  • Inflammatory Bowel Disease

    Inflammatory bowel disease is a term used to describe disorders that involve chronic inflammation of the digestive tract. The two main types are Crohn's disease and ulcerative colitis. Crohn's disease can affect any part of the gastrointestinal tract, while ulcerative colitis is limited to the colon and rectum. Symptoms often include diarrhea, abdominal pain, fatigue, and weight loss. The inflammation can lead to complications such as strictures, fistulas, and malnutrition. The exact cause is unknown, but it is thought to involve an abnormal immune response to gut bacteria.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517334-18-00Protocol codeTOASSTEstimated enrolment530 patientsSponsorKantonsspital Baden AG

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