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NCT03003572Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
185 (estimated)
First submitted
22 Dec 2016
Start date
27 Mar 2018
Primary completion date
30 Jun 2027
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
NCT number
NCT03003572

What you commit to

  • Study type: Observational
  • Planned participants: 185
  • From 27 Mar 2018 to the primary completion date, 30 Jun 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion

Other illness

  • Secondary Sjögren's syndrome
  • Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)
  • Has any current signs or symptoms of active infection

Other

  • Incapacity or refusal to sign the informed consent form
  • Incapacity or refusal to perform the follow-up examinations required by the study

Who the study is looking for

  • Primary Sjögren's syndrome according to the American-European Consensus Criteria)
  • Informed and having signed the study consent form

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH Pierre Oudot
Coordinator of this site? Confirm its status
BourgoinFranceNot yet recruiting
CHU Estaing Clermont - Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
CHU Grenoble Alpes
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
Hôpital de la Croix Rousse
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Hopital Edouard Herriot - CHU Lyon
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
CH Lyon Sud
Coordinator of this site? Confirm its status
LyonFranceRecruiting
CHU Reims
Coordinator of this site? Confirm its status
ReimsFranceNot yet recruiting
CHU Saint-Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.