Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity (I GET DRY)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Primary Sjögren's Syndrome

Treatments: Other: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT03003572

1608171

ANSM (Other Identifier)

Details and patient eligibility

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).

Enrollment: 185 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

185 participants in 1 patient group

patients with primary Sjögren's syndrome

Description:

Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.

Treatment:

Other: Blood samples