Evaluating a Biomarker for Disease Activity in Primary Sjögren's Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the presence of autoreactive anti-Ro/SSA immunoglobulin E (IgE) as a potential biomarker for disease activity in patients with Primary Sjögren's Syndrome (pSS). It will include consecutive patients diagnosed with pSS, either newly diagnosed or previously known, and will measure the levels of anti-Ro/SSA IgE in their blood samples. The study will determine if higher levels of this biomarker correlate with active disease, as defined by the EULAR Sjögren Syndrome Disease Activity Index. The findings could enhance the understanding of disease activity and improve patient management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

• CHU Estaing - Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• CHU Grenoble Alpes
  Grenoble, France Recruiting
• Hôpital de la Croix Rousse
  Lyon, France Recruiting
• CH Lyon Sud
  Lyon, France Recruiting
• Chu Saint-Etienne
  Saint-Etienne, France Recruiting
• CH Pierre Oudot
  Bourgoin, France Not yet recruiting

Study contacts

• Principal investigator: Pascal CATHEBRAS, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Pascal CATHEBRAS, MD PhD
• Email: pascal.cathebras@chu-st-etienne.fr
• Phone: (0)477828342

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.