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

NCT ID: NCT03003572

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-27

Study Completion Date

2027-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Primary Sjögren's Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood samples

Intervention Type OTHER

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

Interventions

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Blood samples

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal CATHEBRAS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CH Pierre Oudot

Bourgoin, , France

Site Status NOT_YET_RECRUITING

CHU Estaing - Clermont Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

CHU Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Hôpital de la Croix Rousse

Lyon, , France

Site Status RECRUITING

CH Lyon Sud

Lyon, , France

Site Status RECRUITING

Hôpital Edouard Herriot - CHU Lyon

Lyon, , France

Site Status NOT_YET_RECRUITING

CHU Reims

Reims, , France

Site Status NOT_YET_RECRUITING

Chu Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pascal CATHEBRAS, MD PhD

Role: CONTACT

[email protected]
(0)477828342 ext. +33

Florence RANCON, CRA

Role: CONTACT

[email protected]
(0)477120284 ext. +33

Facility Contacts

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Marielle ROUX, MD

Role: primary

Marc RUIVARD, MD PhD

Role: primary

Laurence BOULLET, MD PhD

Role: primary

Pascal SEVE, MD

Role: primary

Jean-Christophe LEGA, MD

Role: primary

Arnaud HOT, MD PhD

Role: primary

Pascal CATHEBRAS, MD PhD

Role: primary

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1608171

Identifier Type: -

Identifier Source: org_study_id

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