RecruitingNCT03003572

Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

185 participants

Start Date

Mar 27, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a specific antibody (anti-Ro/SSA IgE) found in the blood of patients with primary Sjögren's syndrome — an autoimmune disease that mainly causes dry eyes and dry mouth — to see if it can be used to measure how active the disease is. **You may be eligible if...** - You have been diagnosed with primary Sjögren's syndrome according to established international medical criteria - You have read and signed the informed consent form **You may NOT be eligible if...** - You have secondary Sjögren's syndrome (caused by another autoimmune disease like rheumatoid arthritis) - You have another systemic autoimmune disease (such as rheumatoid arthritis, ANCA-associated vasculitis, or mixed connective tissue disease) - You are unable or unwilling to sign the informed consent form - You are unable or unwilling to attend the required follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood samples

Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).


Locations(8)

CH Pierre Oudot

Bourgoin, France

CHU Estaing - Clermont Ferrand

Clermont-Ferrand, France

CHU Grenoble Alpes

Grenoble, France

Hôpital de la Croix Rousse

Lyon, France

CH Lyon Sud

Lyon, France

Hôpital Edouard Herriot - CHU Lyon

Lyon, France

CHU Reims

Reims, France

Chu Saint-Etienne

Saint-Etienne, France

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NCT03003572


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