Active not recruitingPHASE3INTERVENTIONAL

3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol

This study, called 3TR, is researching Systemic Lupus Erythematosus (SLE), a condition where the body's immune system mistakenly attacks healthy tissues. People with lupus often have periods of illness called 'flares' and times when they feel better. The main goal is to find better ways to predict when flares might happen and how different treatments affect individuals. Researchers will collect various samples like blood, urine, and saliva from people with lupus. By looking closely at tiny details in these samples, they hope to discover unique patterns that can help doctors understand the disease better, offer more personalised treatments, and hopefully prevent flares in the future. The study involves many research centres across Europe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University Hospital, Brest

Enrolment target

Start

29 Nov 2022

Estimated completion

01 Nov 2026

Systemic Lupus Erythematosus (SLE)

What is this study about?

The 3TR study is looking at Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition where your immune system, which normally fights off infections, mistakenly attacks healthy parts of your body. This can cause a wide range of symptoms and can affect different organs.

People with lupus often experience 'flares' – periods when their symptoms get worse – followed by times when they feel better or the disease is quiet. These flares can sometimes cause damage to organs over time. At the moment, doctors don't have a reliable way to predict which patients with quiet disease are most likely to experience a flare. This study aims to change that by looking for clues in your body's make-up.

This project is a big effort involving many researchers across Europe. They will collect different types of samples, like blood, urine, saliva, and stool, from people with lupus. By carefully studying these samples, they hope to find tiny biological markers or 'biosignatures' that could help predict flares or show how well a treatment might work. Ultimately, the goal is to develop more personalised treatments and strategies to help people with lupus manage their condition better and reduce the impact of flares.

Key takeaways

This study aims to better understand lupus (SLE) flares and treatment responses.
It involves collecting different types of samples like blood and urine.
The goal is to find ways to predict flares and personalise treatments.
No new medicines are given in this study.
Your participation could help future lupus patients.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) based on specific medical criteria. Your lupus should also generally be quiet or stable, meaning you're not having a severe flare at the moment.

It's important that you are able to understand what the study involves and agree to take part. You can be taking most usual lupus medications, though there are some specific rules around certain powerful medications if you've recently started them or had a change in dose.

You cannot join the study if you are pregnant or breastfeeding. Also, if you've recently started high-dose steroids or other strong immune-suppressing medicines within the last month, you might not be able to participate at this time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a diagnosis of Systemic Lupus Erythematosus (SLE)?
Are you able to understand and agree to take part in the study?
Are you currently not pregnant or breastfeeding?
Have you recently started or changed your dose of high-dose steroids or strong immune-suppressing medicines within the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be followed by the research team over a period of time. This will involve regular visits to the clinic where the research team will collect various samples from you. These samples include blood, urine, saliva, and sometimes stool samples. In some cases, a small tissue sample might also be collected.

The study aims to track changes in your body over time, so you would have follow-up appointments. There are no new or experimental medications involved in this study; it's focused on understanding the disease and how current treatments affect patients. The total duration of your involvement would be explained in detail by the study team, and it involves a series of regular check-ups and sample collections.

Potential risks and benefits

Taking part in this study might not offer direct personal health benefits, but your contribution is vital for advancing our understanding of lupus, which could lead to better treatments for future patients. The main risks are minor discomfort or bruising from blood draws, and the time commitment for clinic visits and sample collections. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

01- CHU Brest
Verified postcode
Brest, France

Common questions

What is Systemic Lupus Erythematosus (SLE)?

It's a long-term condition where your immune system mistakenly attacks healthy tissues in your body, causing inflammation and damage.

What is a 'flare' in lupus?

A flare is when your lupus symptoms become more active or worsen, often requiring changes in your treatment.

What kind of samples will be collected?

Researchers will collect samples like blood, urine, saliva, and stool. Sometimes, a tiny tissue sample might also be needed.

Will I receive new medicine in this study?

No, this study does not involve new medicines. It focuses on understanding lupus and how current treatments work.

How long will I be involved in the study?

The study will involve regular follow-up visits over a period of time, which the research team will explain fully.