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

NCT03003572 · Centre Hospitalier Universitaire de Saint Etienne
In plain English

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About this study
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 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
Study design
Enrollment target: 185 participants
Age groups: adult, older_adult
Timeline
Starts: 2018-03-27
Estimated completion: 2027-06
Last updated: 2025-03-18
Interventions
Other: Blood samples
Primary outcomes
  • Proportion of anti-Ro/SSA IgE positive patients (Day 1)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · other
With: Ministry of Health, France
Contacts & investigators
ContactPascal CATHEBRAS, MD PhD · contact · pascal.cathebras@chu-st-etienne.fr · (0)477828342
ContactFlorence RANCON, CRA · contact · florence.rancon@chu-st-etienne.fr · (0)477120284
InvestigatorPascal CATHEBRAS, MD PhD · principal_investigator, CHU SAINT-ETIENNE
All locations (8)
CH Pierre OudotNot Yet Recruiting
Bourgoin, France
CHU Estaing - Clermont FerrandRecruiting
Clermont-Ferrand, France
CHU Grenoble AlpesRecruiting
Grenoble, France
Hôpital de la Croix RousseRecruiting
Lyon, France
CH Lyon SudRecruiting
Lyon, France
Hôpital Edouard Herriot - CHU LyonNot Yet Recruiting
Lyon, France
CHU ReimsNot Yet Recruiting
Reims, France
Chu Saint-EtienneRecruiting
Saint-Etienne, France
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity · TrialPath