Clinical trial NCT03003572: Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Official title: Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Sjögren's Syndrome
Keywords: Sjögren's syndrome
Immunoglobulin E
Anti-Ro/SSA
Autoimmune disease
Biomarker
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-12-28
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary Sjögren's syndrome

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of anti-Ro/SSA IgE positive patients
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between anti-Ro/SSA IgE titers and pSS's activity.
timeFrame: Day 1
measure: Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level
timeFrame: Day 1
measure: Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma
timeFrame: 5 years
measure: Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature
timeFrame: Day 1
measure: Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics
timeFrame: Day 1
measure: Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics
timeFrame: Day 1
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Clermont-Ferrand
country: France
facility: CHU Estaing - Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: CH Lyon Sud
city: Lyon
country: France
facility: Hôpital Edouard Herriot - CHU Lyon
city: Reims
country: France
facility: CHU Reims
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal CATHEBRAS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: