Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Recruiting · NCT03003572 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
8 locations listed.
- 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