Tests blood markers to track activity of primary Sjögren's syndrome
Studies anti-Ro/SSA IgE blood levels in adults with primary Sjögren's syndrome.
Plain-language title generated from the registry record
Registry title: Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Key facts
- Where
- Bourgoin, Clermont-Ferrand, Grenoble, Lyon, Reims, and Saint-Etienne, FranceSee the 8 sites
Where in France
- CH Pierre OudotBourgoin, FranceNot yet recruiting
- CHU Estaing Clermont - FerrandClermont-Ferrand, FranceTaking people
- CHU Grenoble AlpesGrenoble, FranceTaking people
- CH Lyon SudLyon, FranceTaking people
- Hôpital de la Croix RousseLyon, FranceTaking people
- Hopital Edouard Herriot - CHU LyonLyon, FranceNot yet recruiting
- CHU ReimsReims, FranceNot yet recruiting
- CHU Saint-EtienneSaint-Etienne, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Trial code
- NCT03003572
- Record updated
- 6 May 2026
- Original description
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).Read full original descriptionShow less
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
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).
Inclusion: Primary Sjögren's syndrome according to the American-European Consensus Criteria); Informed and having signed the study consent form.
Exclusion: Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion; Secondary Sjögren's syndrome; Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…); Has any current signs or symptoms of active infection; Incapacity or refusal to sign the informed consent form; Incapacity or refusal to perform the follow-up examinations required by the study.