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Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in Systemic Lupus Erythematosus (DYSALARM-322)

This research is investigating certain natural substances found in the blood, called autoantibodies (anti-C1s, anti-HMGB1, and anti-C1q), in people with active lupus. Lupus is a long-term condition where the body's immune system mistakenly attacks its own healthy tissues. We're trying to understand how these specific autoantibodies might play a role in causing lupus symptoms and the damage seen in the body. The study will look at blood samples from 30 lupus patients to find out exactly what these autoantibodies target and how they affect important body functions. By learning more about these substances, we hope to improve our understanding of lupus, which could eventually lead to better ways to manage the condition.

At a glance

Status
Recruiting
Sponsor
University Hospital, Grenoble
Enrolment target
30
Start
11 Mar 2022
Estimated completion
10 Sep 2025

What is this study about?

Lupus (Systemic Lupus Erythematosus or SLE) is a condition where your body's defence system, called the immune system, mistakenly attacks your own healthy tissues. This can lead to widespread inflammation and damage in many parts of the body. In people with lupus, the body often produces special proteins called 'autoantibodies' that target its own components. This study is focusing on three specific types of these autoantibodies: anti-C1s, anti-HMGB1, and anti-C1q.

Scientists believe that some proteins involved in how our immune system works, specifically C1q and C1s, and another protein called HMGB1, might not be working correctly in people with lupus. These autoantibodies might be interfering with how these proteins usually behave. We don't fully understand yet what these autoantibodies do, especially outside of their well-known roles in the body's natural defence system. This study aims to shed more light on this mystery.

This small study will involve 30 patients who have active lupus. Researchers will take blood samples, which are already part of regular patient care. They will then look closely at these samples to see what specific parts of the body these autoantibodies are targeting. They will also explore how these autoantibodies affect the way certain parts of your immune system and other body processes work. By understanding this better, we hope to gain valuable insights into what causes lupus symptoms.

Key takeaways

  • A research study looking at specific immune proteins in lupus patients.
  • Aims to understand what causes lupus symptoms.
  • Uses existing blood samples from routine care.
  • Could help develop better lupus treatments in the future.
  • Involves 30 patients with active lupus.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and weigh 40 kilograms (about 6 stone 4 pounds) or more. You also need to have valid health insurance. Most importantly, you must have a confirmed diagnosis of lupus based on specific medical criteria, and your lupus should be active, particularly affecting your joints and/or kidneys, as measured by a specific lupus activity score (SLEDAI score over 5).

There are also some reasons why you wouldn't be able to join the study. These include if you are under 18, pregnant, or breastfeeding. Also, if you are undergoing dialysis or plasma exchange treatments, you wouldn't be able to participate. This also applies to anyone who is legally protected, such as those under a guardianship, in prison, or compulsorily hospitalised.

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.

  1. Are you 18 years old or older?
  2. Do you weigh at least 40 kilograms (about 6 stone 4 pounds)?
  3. Do you have a current diagnosis of lupus with active symptoms, especially affecting your joints or kidneys?
  4. Are you NOT pregnant or breastfeeding?
  5. Are you NOT currently on dialysis or plasma exchange treatments?
Answer every question to see your result.

What does participation involve?

This is a pilot study, meaning it's a small initial investigation. It involves taking blood samples that are already part of your routine medical care for your lupus. You will not receive any new medication as part of this study. There is no specific duration mentioned for individual patient participation beyond the collection of routine blood samples. It focuses on laboratory analysis of these samples to understand the autoantibodies.

Potential risks and benefits

The potential benefits of taking part in this study include contributing to a better understanding of lupus, which could lead to improved treatments in the future. As the study uses blood samples already collected during routine care, the direct risks to you are minimal. The main risk would be the usual small risks associated with blood drawing, such as slight bruising or discomfort. You are always free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

  • CHU Grenoble Alpes
    Verified postcode
    Grenoble, France· Recruiting
  • AP-HM_Hôpital de la Conception
    Verified postcode
    Marseille, France· Recruiting

Common questions

What is lupus?

Lupus is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues and organs.

What are autoantibodies?

Autoantibodies are special proteins made by your immune system that, in conditions like lupus, wrongly target and attack your own body's cells or tissues.

Will I get new medication in this study?

No, this study does not involve giving new medication. It uses blood samples already taken during your routine medical care.

What does a 'pilot study' mean?

A pilot study is a small, initial research project designed to test an idea or method before conducting a larger, more detailed study.

How many people are in this study?

This study plans to include 30 patients who have active lupus.

How to find out more

Chantal DUMESTRE-PERARD, Professor

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in Systemic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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