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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Primary Sjögren's syndrome according to the American-European Consensus Criteria) - Informed and having signed the study consent form Who Should NOT Join This Trial: - Secondary Sjögren's syndrome - Other systemic autoimmune conditions (where your immune system attacks your own body) (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…) - Incapacity or refusal to sign the willing to sign a consent form form - Incapacity or refusal to perform the follow-up examinations required by the study - Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion - Has any current signs or symptoms of active infection Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Primary Sjögren's syndrome according to the American-European Consensus Criteria) * Informed and having signed the study consent form Exclusion Criteria: * Secondary Sjögren's syndrome * Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…) * Incapacity or refusal to sign the informed consent form * Incapacity or refusal to perform the follow-up examinations required by the study * Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion * Has any current signs or symptoms of active infection

Treatments Being Tested

OTHER

Blood 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