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
- Diseases
- Sjögren's disease
- 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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Pierre Oudot Coordinator of this site? Confirm its status | Bourgoin | France | Not yet recruiting |
| CHU Estaing Clermont - Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hopital Edouard Herriot - CHU Lyon Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| CH Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Not yet recruiting |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.