Informations générales (source: ClinicalTrials.gov)
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity (I GET DRY)
Observational
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
mars 2018
juin 2027
05 avril 2025
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH Lyon Sud - 69495 - Lyon - France | Jean-Christophe LEGA, MD | Contact (sur clinicalTrials) | |||
| CH Pierre Oudot - 38300 - Bourgoin-Jallieu - France | Marielle ROUX, MD | Contact (sur clinicalTrials) | |||
| CHU Estaing - Clermont Ferrand - 63000 - Clermont-Ferrand - France | Marc RUIVARD, MD PhD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38700 - Grenoble - France | Laurence BOULLET, MD PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| Chu Saint-Etienne - 42055 - Saint Etienne - France | Pascal CATHEBRAS, MD PhD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - 69317 - Lyon - France | Pascal SEVE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - CHU Lyon - Lyon - France | Arnaud HOT, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Primary Sjögren's syndrome according to the American-European Consensus Criteria)
- Informed and having signed the study consent form
- Primary Sjögren's syndrome according to the American-European Consensus Criteria)
- Informed and having signed the study consent form
- 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