Actively Recruiting
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-05-06
185
Participants Needed
8
Research Sites
479 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
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).
CONDITIONS
Official Title
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary Sj�f6gren's syndrome according to the American-European Consensus Criteria
- Informed and having signed the study consent form
You will not qualify if you...
- Secondary Sj�f6gren's syndrome
- Other systemic autoimmune disease (e.g. rheumatoid arthritis, 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, TNF antagonists or interferon during the 6 months prior to the inclusion
- Has any current signs or symptoms of active infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
CH Pierre Oudot
Bourgoin, France, 38300
Not Yet Recruiting
2
CHU Estaing - Clermont Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
3
CHU Grenoble Alpes
Grenoble, France, 38700
Actively Recruiting
4
Hôpital de la Croix Rousse
Lyon, France, 69317
Actively Recruiting
5
CH Lyon Sud
Lyon, France, 69495
Actively Recruiting
6
Hôpital Edouard Herriot - CHU Lyon
Lyon, France
Not Yet Recruiting
7
CHU Reims
Reims, France
Not Yet Recruiting
8
Chu Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
P
Pascal CATHEBRAS, MD PhD
CONTACT
F
Florence RANCON, CRA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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