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

NCT03003572 | Recruiting

• 2 other identifiers: 1608171ANSM
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 8

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).

Conditions

Primary Sjögren's Syndrome

Keywords

Sjögren's syndrome; Immunoglobulin E; Anti-Ro/SSA; Autoimmune disease; Biomarker

Outcome Measures

Primary Outcomes (1)

• Proportion of anti-Ro/SSA IgE positive patients

  Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5

  Day 1

Secondary Outcomes (6)

• Correlation between anti-Ro/SSA IgE titers and pSS's activity.

  Day 1

• Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level

  Day 1

• Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma

  5 years

• Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature

  Day 1

• Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics

  Day 1

Study Arms (1)

patients with primary Sjögren's syndrome

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.

Other: Blood samples

Interventions

Blood samples OTHER

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

patients with primary Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary Sjögren's syndrome

You may qualify if:

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

You may not qualify if:

• 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 any current signs or symptoms of active infection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (8)

CH Pierre Oudot

Bourgoin, 38300, France

NOT YET RECRUITING

CHU Estaing - Clermont Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU Grenoble Alpes

Grenoble, 38700, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, 69317, France

RECRUITING

CH Lyon Sud

Lyon, 69495, France

RECRUITING

Hôpital Edouard Herriot - CHU Lyon

Lyon, France

NOT YET RECRUITING

CHU Reims

Reims, France

NOT YET RECRUITING

Chu Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sjogren's Syndrome; Autoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pascal CATHEBRAS, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal CATHEBRAS, MD PhD

CONTACT

(0)477828342; pascal.cathebras@chu-st-etienne.fr

Florence RANCON, CRA

CONTACT

(0)477120284; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 28, 2016
• Study Start: March 27, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)