Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
NCT03003572
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
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
Conditions2
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT03003572