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

Primary Sjögren's Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03003572
• Other study ID #: 1608171
• Secondary ID: ANSM
• Status: Recruiting
• Start date: March 27, 2018
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Pascal CATHEBRAS, MD PhD
• Phone: (0)477828342
• Email: pascal.cathebras[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CH Pierre Oudot	Bourgoin-Jallieu
France	CHU Estaing - Clermont Ferrand	Clermont-Ferrand
France	CHU Grenoble Alpes	Grenoble
France	CH Lyon Sud	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Edouard Herriot - CHU Lyon	Lyon
France	CHU Reims	Reims
France	Chu Saint-Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between anti-Ro/SSA IgE titers and pSS's activity.	pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI).; Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.	Day 1
Secondary	Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).; The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI).; If ESSPRI=5: symptomatology whose intensity felt by the patient is not acceptable.; If ESSPRI<5: symptomatology whose intensity felt by the patient is acceptable.	Day 1
Secondary	Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).; There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma.	5 years
Secondary	Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).; Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.	Day 1
Secondary	Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).; Composite outcome of clinical and biologic characteristics is describe below.; Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.; Biologic characteristics: anti-Ro/SSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes.	Day 1
Secondary	Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics	Anti-La/SSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).; Composite outcome of clinical and biologic characteristics is describe below.; Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.; Biologic characteristics: anti-La/SSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes.	Day 1