Actively Recruiting

Age: 18Years +
All Genders
NCT03003572

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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