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

Last updated: March 17, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Treatment

Blood samples

Clinical Study ID

NCT03003572
1608171
ANSM
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Primary Sjögren's syndrome according to the American-European Consensus Criteria)

  • Informed and having signed the study consent form

Exclusion

Exclusion Criteria:

  • Secondary Sjögren's syndrome

  • Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophilAntibodies (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, TumorNecrosis Factor (TNF) antagonists or interferon during the 6 months prior to theinclusion

  • Has any current signs or symptoms of active infection

Study Design

Total Participants: 185
Treatment Group(s): 1
Primary Treatment: Blood samples
Phase:
Study Start date:
March 27, 2018
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • CH Pierre Oudot

    Bourgoin-Jallieu, 38300
    France

    Site Not Available

  • CHU Estaing - Clermont Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble, 38700
    France

    Active - Recruiting

  • CH Lyon Sud

    Lyon, 69495
    France

    Active - Recruiting

  • Hôpital Edouard Herriot - CHU Lyon

    Lyon,
    France

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon, 69317
    France

    Active - Recruiting

  • CHU Reims

    Reims,
    France

    Site Not Available

  • Chu Saint-Etienne

    Saint Etienne, 42055
    France

    Active - Recruiting

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