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

Inclusion Criteria2

  • Primary Sjögren's syndrome according to the American-European Consensus Criteria)
  • Informed and having signed the study consent form

Exclusion Criteria6

  • 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

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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