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

Overview

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).

Interventions

• Other Blood samples
  Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).

Primary outcome measures

• Proportion of anti-Ro/SSA IgE positive patients [Time frame: Day 1]

Secondary outcome measures (6)

• Correlation between anti-Ro/SSA IgE titers and pSS's activity. [Time frame: Day 1]
• Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level [Time frame: Day 1]
• Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma [Time frame: 5 years]
• Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature [Time frame: Day 1]
• Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics [Time frame: Day 1]
• Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 8 centers

• CH Pierre Oudot — Bourgoin
• CHU Estaing - Clermont Ferrand — Clermont-Ferrand
• CHU Grenoble Alpes — Grenoble
• Hôpital de la Croix Rousse — Lyon
• CH Lyon Sud — Lyon
• Hôpital Edouard Herriot - CHU Lyon — Lyon
• CHU Reims — Reims
• Chu Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT03003572 · 1608171 · ANSM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗