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

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Universitaire de Saint Etienne
NCT03003572 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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) wi

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📋 Eligibility rules (as published)
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
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What it tests

  • Blood samples
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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