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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Informed and having signed the study consent form

Locations
Other Locations
France
CH Pierre Oudot
NOT_YET_RECRUITING
Bourgoin
CHU Estaing - Clermont Ferrand
RECRUITING
Clermont-ferrand
CHU Grenoble Alpes
RECRUITING
Grenoble
CH Lyon Sud
RECRUITING
Lyon
Hôpital de la Croix Rousse
RECRUITING
Lyon
Hôpital Edouard Herriot - CHU Lyon
NOT_YET_RECRUITING
Lyon
CHU Reims
NOT_YET_RECRUITING
Reims
Chu Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Pascal CATHEBRAS, MD PhD
pascal.cathebras@chu-st-etienne.fr
(0)477828342
Backup
Florence RANCON, CRA
florence.rancon@chu-st-etienne.fr
(0)477120284
Time Frame
Start Date: 2018-03-27
Estimated Completion Date: 2027-06
Participants
Target number of participants: 185
Treatments
patients with primary Sjögren's syndrome
Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.
Authors
Laurence BOULLET
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov