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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Proportion of anti-Ro/SSA IgE positive patients — Day 1
  Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5

Trial sites (8)

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